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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01265 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2013-0819 | |||
| N01-CN-2012-00034 | |||
| HHSN261201200034I | |||
| 2015-0819 | Other Identifier | UT MD Anderson Cancer Center | |
| MDA2013-02-02 | Other Identifier | DCP | |
| N01CN00034 | U.S. NIH Grant/Contract | View source | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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This randomized phase II trial studies the safety of and how well aspirin works in preventing Barrett's esophagus from returning after it has been successfully eliminated by radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus for the levels of a specific protein that is linked to developing Barrett's esophagus may help doctors learn whether aspirin can prevent it from returning after it has been successfully treated.
PRIMARY OBJECTIVES:
I. To conduct a randomized, double blind, placebo-controlled phase II chemoprevention trial, investigating whether supplementation with aspirin 325 mg/day for 12 months is safe and reduces the expression of CDX2 messenger ribonucleic acid (mRNA) (a biomarker which has been associated with the risk of developing Barrett's esophagus [BE]) in comparison to placebo after successful radiofrequency ablation (RFA).
SECONDARY OBJECTIVES:
I. To assess safety at 12 months. II. To assess differences in the expression of CDX2 at 18 months, activation status of NF-kB by assessing levels of total and phosphorylated (phospho)-p65 and cytoplasmic to nuclear translocation of phospho-p65 which is likely to be affected by aspirin.
III. To assess the prostanoid marker, prostaglandin E2, and prostaglandin synthases, which are known to respond to aspirin and to correlation with clinicopathological factors in the esophageal cancer.
IV. To assess differences in the expression of proinflammatory cytokines known to induce activation of NFkB, i.e., TNFalpha, IL-1beta, IL-6, IL-10, IL-17A, IL-23 will be measured.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive aspirin orally (PO) once daily (QD) for 12 months.
ARM B: Patients receive placebo PO QD for 12 months.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, and 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (aspirin) | Experimental | Patients receive aspirin PO QD for 12 months. |
|
| Arm B (placebo) | Placebo Comparator | Patients receive placebo PO QD for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Change of CDX2 mRNA Levels in Esophageal Mucosa Between Participants Taking Aspirin and Placebo at 12 Months (Location A) | Measured the absolute and relative values in percentage of biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction.) The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Baseline and 12 months |
| Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo (Location B) | Measured the absolute and relative values change in the biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Baseline and 12 months |
| Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo ( Location C) | Measured the absolute and relative values change in the biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Baseline and 12 months |
| Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location A) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) | Number of Participants experiencing adverse events by maximum grade (grades 1-3). Safety assessed by comparison of adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. AEs will be assessed according to the CTCAE grade associated with the AE term. All adverse events are listed in the Adverse Events Overview. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in the Prostanoid Marker, Prostaglandin E2, and Prostaglandin Synthases | Listed separately as #7-13 Secondary Outcome Measures. | Baseline up to 18 months |
| Differences in the Expression of Proinflammatory Cytokines Known to Induce Activation of NFkB |
Inclusion Criteria:
Exclusion Criteria:
Inability to abstain from, NSAID (including aspirin), and selective COX-2 inhibitor therapy at the time of randomization through the completion of the study (the study period is defined as baseline to exit endoscopy at 18 months after randomization which defines the completion of the study); participants may take Tylenol and non-NSAID pain relievers
Current or planned use of anticoagulant drugs such as: warfarin, heparin, low molecular weight heparin, Plavix, or Aggrenox throughout the course of the study
Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 1 month prior to starting aspirin or placebo on this study; consultation with the participant's primary care provider will be obtained prior to stopping any agent; the use of the following drugs or drug classes is prohibited during aspirin/placebo treatment:
Individuals with uncontrolled renal insufficiency or renal failure
Participants with fundoplication within the past year, bariatric surgery or any other major upper gastrointestinal (GI) surgery; fundoplication more than one year ago will not be grounds for exclusion; cholecystectomy will not be grounds for exclusion
History of invasive cancer diagnosis =< 12 months prior to randomization, excepting nonmelanoma skin cancer; patients with T1a adenocarcinoma of the esophagus arising in the setting of Barrett's esophagus are eligible for enrollment in the trial
History of cancer treatment =< 12 months prior to randomization, excepting hormonal therapy (except treatment for non-melanoma skin cancer or carcinoma-in-situ of the cervix)
Receipt of any other investigational agents =< 3 months prior to randomization, except innocuous agents with no known interaction with the study agents (e.g., standard dose multivitamins or topical agents for limited skin conditions), at the discretion of the protocol lead investigator at each participating site
History of allergic reactions attributed to aspirin or compounds of similar chemical or biologic composition to the study agent
History of endoscopically or radiographically diagnosed peptic ulcer disease with upper GI bleeding during the past 5 years or history of endoscopically or radiographically diagnosed peptic ulcer disease with upper GI bleeding any time while taking aspirin
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bleeding disorder, vitamin K deficiency, alcohol abuse (defined as ingestion of 3 or more drinks per day) or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women
Breast feeding women
Surveillance biopsies demonstrating residual BE at qualifying exam
Presence of an esophageal stricture defined as "any recognizable change in esophageal luminal caliber that is accompanied by symptoms of dysphagia, or any asymptomatic narrowing that either will not allow any adult endoscope to pass or allows passage with resistance"
Patients with human immunodeficiency virus (HIV) infection
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Bresalier | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States | ||
| UCHealth University of Colorado Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29948566 | Derived | Bresalier RS. Chemoprevention of Barrett's Esophagus and Esophageal Adenocarcinoma. Dig Dis Sci. 2018 Aug;63(8):2155-2162. doi: 10.1007/s10620-018-5149-6. |
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21 participants were randomized due to 12 were unevaluable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Aspirin) | Participants received aspirin 325 mg orally (PO) once daily for 12 months |
| FG001 | Arm B (Placebo) | Participants received placebo daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2019 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Placebo Administration | Other | Given PO |
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| Questionnaire Administration | Other | Ancillary studies |
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Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.
| Baseline and 12 months |
| Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location B) | Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment)The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Baseline and 12 months |
| Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Baseline and 12 months |
| Up to 18 months |
| Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location A) | Measured the change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Baseline to 18 months |
| Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location B) | Measured change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Up to 18 months |
| Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location C) | Measured the change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Baseline to 18 months |
| Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location A) | Measured the change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Baseline up to 18 months |
| Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location B) | Measured the change in the biomarker levels of p-p65/total p65 in the esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Baseline up to 18 months |
| Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location C) | Measured the change in the biomarker levels p-p65/total p65 in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Baseline up to 18 months |
| Differences in the Change of txb2 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of tbx2 at 12 Months (Location B) | Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of tbx2 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of pge1 at 12 Months ( Location A) | Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of pge1 at 12 Months (Location B) | Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of pge1 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of pge2 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of pge2 at 12 Months (Location B) | Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change in pge2 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of a13pge1 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of a13pge1 at 12 Months ( Location B) | Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change in a13pge1 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of a13pge2 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of a13pge2 at 12month (Location B) | Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Differences in the Change of a13pge2 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Baseline and 12 months |
| Baseline up to 18 months |
| Incidence of Barrett's Esophagus (BE) Recurrence | Baseline up to 18 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Kansas City Veterans Affairs Medical Center | Kansas City | Missouri | 64128 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | United States |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Saint Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Aspirin) | Participants received aspirin 325 mg orally (PO) once daily for 12 months |
| BG001 | Arm B (Placebo) | Participants received placebo daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline cdx2/normalized to GAPDH | Median | Full Range | percentage of biomarker levels |
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| Baseline p-p65/total p65 corrected for tubulin | Median | Full Range | percentage of biomarker levels |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in the Change of CDX2 mRNA Levels in Esophageal Mucosa Between Participants Taking Aspirin and Placebo at 12 Months (Location A) | Measured the absolute and relative values in percentage of biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction.) The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | 1 participant withdrew consent and decided to take a baby aspirin, per PCP recommendation in the Aspirin arm and 1 participant was lost to follow up, 1 participant withdrew consent, and 1 participant adverse event in the Placebo arm | Posted | Median | Full Range | change of percentage of CDX2 mRNA levels | Baseline and 12 months |
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| Primary | Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo (Location B) | Measured the absolute and relative values change in the biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Posted | Median | Full Range | change of percentage of CDX2 mRNA levels | Baseline and 12 months |
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| Primary | Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo ( Location C) | Measured the absolute and relative values change in the biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Posted | Median | Full Range | change of percentage of CDX2 mRNA levels | Baseline and 12 months |
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| Primary | Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | 1 participant withdrew consent and decided to take a baby aspirin, per PCP recommendation in the Aspirin arm and 1 participant was lost to follow up, 1 participant withdrew consent, and 1 participant adverse event in the Placebo arm. | Posted | Median | Full Range | change of % of p-p65/total p65 levels | Baseline and 12 months |
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| Primary | Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location B) | Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment)The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Posted | Median | Full Range | change of % of p-p65/total p65 levels | Baseline and 12 months |
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| Primary | Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Posted | Median | Full Range | change of % of p-p65/total p65 levels | Baseline and 12 months |
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| Secondary | Number of Participants With Adverse Events (AE) | Number of Participants experiencing adverse events by maximum grade (grades 1-3). Safety assessed by comparison of adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. AEs will be assessed according to the CTCAE grade associated with the AE term. All adverse events are listed in the Adverse Events Overview. | Posted | Count of Participants | Participants | Up to 18 months |
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| Secondary | Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location A) | Measured the change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Posted | Median | Full Range | percentage of biomarkers level | Baseline to 18 months |
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| Secondary | Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location B) | Measured change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Posted | Median | Full Range | percentage of biomarkers level | Up to 18 months |
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| Secondary | Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location C) | Measured the change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry. | Posted | Median | Full Range | percentage of biomarkers level | Baseline to 18 months |
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| Secondary | Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location A) | Measured the change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Participants with biopsies available at 18-months. | Posted | Median | Full Range | percentage of biomarkers level | Baseline up to 18 months |
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| Secondary | Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location B) | Measured the change in the biomarker levels of p-p65/total p65 in the esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Posted | Median | Full Range | percentage of biomarkers level | Baseline up to 18 months |
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| Secondary | Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location C) | Measured the change in the biomarker levels p-p65/total p65 in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry. | Posted | Median | Full Range | percentage of biomarkers level | Baseline up to 18 months |
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| Secondary | Differences in the Change of txb2 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of txb2 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of tbx2 at 12 Months (Location B) | Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of tbx2 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of tbx2 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of tbx2 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of pge1 at 12 Months ( Location A) | Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of pge1 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of pge1 at 12 Months (Location B) | Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of pge1 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of pge1 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of pge1 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of pge2 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of pge2 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of pge2 at 12 Months (Location B) | Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of pge2 levels | Baseline and 12 months |
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| Secondary | Differences in the Change in pge2 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of pge2 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of a13pge1 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of a13pge1 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of a13pge1 at 12 Months ( Location B) | Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of a13pge1 levels | Baseline and 12 months |
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| Secondary | Differences in the Change in a13pge1 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of a13pge1 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of a13pge2 at 12 Months (Location A) | Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of a13pge2 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of a13pge2 at 12month (Location B) | Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | change of percentage of a13pge2 levels | Baseline and 12 months |
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| Secondary | Differences in the Change of a13pge2 at 12 Months (Location C) | Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses. | Posted | Median | Full Range | percentage of a13pge2 biomarkers level | Baseline and 12 months |
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| Other Pre-specified | Differences in the Prostanoid Marker, Prostaglandin E2, and Prostaglandin Synthases | Listed separately as #7-13 Secondary Outcome Measures. | Not Posted | Baseline up to 18 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Differences in the Expression of Proinflammatory Cytokines Known to Induce Activation of NFkB | Differences in the Expression of Proinflammatory Cytokines (a secondary endpoint) was not measured as there was insufficient biopsy material to perform these measurements. Alternatively we measured multiple additional prostaglandins and downstream markers as secondary endpoints since we were able to use smaller amounts of sample on a platform which allowed multiple measurements. These results are detailed in section which lists prostanoid measurements. | Posted | Baseline up to 18 months |
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| Other Pre-specified | Incidence of Barrett's Esophagus (BE) Recurrence | Not Posted | Baseline up to 18 months | Participants |
baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Aspirin) | Participants receive aspirin orally (PO) once daily (QD) for 12 months | 0 | 8 | 3 | 8 | 7 | 8 |
| EG001 | Arm B (Placebo) | Participants received placebo daily | 0 | 8 | 2 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subdural Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Drainage of Subdural Hematoma | Surgical and medical procedures | CTCAE or Verbatim | Systematic Assessment |
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| Parotidectomy | Surgical and medical procedures | CTCAE or Verbatim | Systematic Assessment |
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| Small Bowel Obstruction | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Severe Stenosis | Musculoskeletal and connective tissue disorders | CTCAE or Verbatim | Systematic Assessment |
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| Hiatus Hernia Repair | Surgical and medical procedures | CTCAE or Verbatim | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain/Abdominal pain with Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Acid Reflux | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE or Verbatim | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE or Verbatim | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE or Verbatim | Systematic Assessment |
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| Blood in Stool | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Bruising left arm | Skin and subcutaneous tissue disorders | CTCAE or Verbatim | Systematic Assessment |
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| Cataract Removed | Eye disorders | CTCAE or Verbatim | Systematic Assessment |
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| Chills | General disorders | CTCAE or Verbatim | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Cough/Cough due to Cold Symptoms | Respiratory, thoracic and mediastinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE or Verbatim | Systematic Assessment |
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| Edema-Limbs | General disorders | CTCAE or Verbatim | Systematic Assessment |
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| Eye Pain-Herpes Virus Right Eye | Eye disorders | CTCAE or Verbatim | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE or Verbatim | Systematic Assessment |
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| Fatigue | General disorders | CTCAE or Verbatim | Systematic Assessment |
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| Fusion of Right Great Toe Joint | Surgical and medical procedures | CTCAE or Verbatim | Systematic Assessment |
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| Ganglion Cyst Left Finger | Musculoskeletal and connective tissue disorders | CTCAE or Verbatim | Systematic Assessment |
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| Gout | Musculoskeletal and connective tissue disorders | CTCAE or Verbatim | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE or Verbatim | Systematic Assessment |
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| Gastrointestinal Disorders-Other, specify:Mouth Sores | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Flu like symptoms(Sick/Cough due to cold symptoms/Nasal and chest congestion) | General disorders | CTCAE or Verbatim | Systematic Assessment |
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| Nausea/Nausea and Vomiting | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| PSA out of range | Investigations | CTCAE or Verbatim | Systematic Assessment |
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| Pain | General disorders | CTCAE or Verbatim | Systematic Assessment |
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| Left rotator cuff tear due to fall | Injury, poisoning and procedural complications | CTCAE or Verbatim | Systematic Assessment |
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| Surgical and Medical Procedures-Other, specify-Radiation Therapy | Surgical and medical procedures | CTCAE or Verbatim | Systematic Assessment |
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| Gastrointestinal Disorders-Other, specify: dental crown recemented | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Runny Nose | General disorders | CTCAE or Verbatim | Systematic Assessment |
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| Sinusitis | Infections and infestations | CTCAE or Verbatim | Systematic Assessment |
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| Sinus Surgery for Streptococcus and Staphylococcus Aureus Bacteria Infection | Infections and infestations | CTCAE or Verbatim | Systematic Assessment |
| |
| Small cut/cut on finger taking a long time to heal | General disorders | CTCAE or Verbatim | Systematic Assessment |
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| Rotator Cuff Repair | Surgical and medical procedures | CTCAE or Verbatim | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | CTCAE or Verbatim | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | CTCAE or Verbatim | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE or Verbatim | Systematic Assessment |
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| Diverticulitis | Infections and infestations | CTCAE or Verbatim | Systematic Assessment |
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| Diabetes | Metabolism and nutrition disorders | CTCAE or Verbatim | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE or Verbatim | Systematic Assessment |
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| Hematoma | Vascular disorders | CTCAE or Verbatim | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert S. Bresalier, MD- Professor, Gastroenterology Hepat & Nutr | UT MD Anderson Cancer Center | (713) 745-4340 | rbresali@mdanderson.org |
| Dec 31, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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