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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00384 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB00009213 | Other Identifier | OHSU Knight Cancer Institute | |
| P30CA069533 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies whether esophageal cytology plus fluorescence in situ hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper endoscopy for the early detection of esophageal cancer. Genes are the units of deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that determine many human characteristics. Certain genes in cancer cells may determine how the tumor grows or spreads and how it may respond to different drugs. Part of this study is to test those genes in esophageal cells using FISH.
PRIMARY OBJECTIVES:
I. Determine if sponge cytology with FISH is a reliable screening tool for esophageal dysplasia/cancer, and determine its sensitivity and specificity, compared to the gold standard procedure (upper endoscopy).
SECONDARY OBJECTIVES:
I. Determine if the cytology screening with FISH biomarkers is more cost effective than upper endoscopy for the screening of esophageal cancer and the surveillance of esophageal metaplasia and dysplasia.
II. Determine the limitations and future needs to improve this technique.
OUTLINE:
Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (esophageal cytology, FISH) | Experimental | Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | Undergo esophageal cytology collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Sponge Cytology Using FISH | All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population. | At the time of sponge cytology and EGD |
| Specificity of Sponge Cytology Using FISH | All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population. | At the time of sponge cytology and EGD |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test. | At the time of sponge cytology procedure |
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Inclusion Criteria:
Subjects with known esophageal cancer diagnosed by previous endoscopy
Patients determined to be at risk for esophageal cancer:
Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:
Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky >= 30%) will be included
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hunter | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Esophageal Cell Harvesting Procedure | Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Esophagogastroduodenoscopy | Procedure | Undergo standard EGD or endoscopy |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Tolerability of FISH Spongy Cytology |
Tolerability is defined as the patient's willingness to repeat procedure. |
| After completion of FISH and EGD |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Esophageal Cell Harvesting Procedure | Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy. |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index, average | Mean | Standard Deviation | kg/m^2 |
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| Number of participants with history of GERD | Count of Participants | Participants |
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| Number of participants with history of Barrett's Esophagus | Count of Participants | Participants |
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| Number of participants with a history of PPI use | Count of Participants | Participants |
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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 | Sensitivity of Sponge Cytology Using FISH | All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population. | Analysis was per protocol | Posted | Number | 95% Confidence Interval | percentage of cases among positive tests | At the time of sponge cytology and EGD |
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| Primary | Specificity of Sponge Cytology Using FISH | All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population. | Per protocol | Posted | Number | 95% Confidence Interval | Percentage of non-cases among neg tests | At the time of sponge cytology and EGD |
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| Secondary | Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test. | Intent to Treat (ITT) | Posted | Number | adverse events | At the time of sponge cytology procedure |
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| Secondary | Tolerability of FISH Spongy Cytology | Tolerability is defined as the patient's willingness to repeat procedure. | Intent to Treat (ITT) | Posted | Number | percentage of subjects tolerating test | After completion of FISH and EGD |
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Adverse Events were collected on patients from time of consent to completion of cell harvesting procedure, up to 24 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esophageal Cell Harvesting Procedure | Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy. | 0 | 50 | 16 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gagging / Discomfort | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Patients who either demonstrated gagging during the procedure and / or expressed discomfort immediately following the study procedure |
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| Emesis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Patients who vomited during or immediately following study procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Hunter, MD | OHSU | 503-494-4937 | hunterj@ohsu.edu |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D004941 | Esophagitis |
| D005764 | Gastroesophageal Reflux |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D005759 | Gastroenteritis |
| D015154 | Esophageal Motility Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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