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This study aims to evaluate the acceptability of a new non-invasive screening device to test for Barrett's esophagus. The investigators will prospectively enroll 100 patients to undergo Cytosponge testing. The time of involvement for an individual will range from 2 weeks to 2 months, depending on the results of the Cytosponge test and time to follow up endoscopy, if indicated.
The incidence of esophageal adenocarcinoma (EAC) has risen over the past half century and continues to have a dismal prognosis. Even though it has been established that Barrett's esophagus (BE) is the precursor lesion to EAC, more than 90% of EAC patients are never diagnosed with BE beforehand. Thus, the opportunity is missed to identify most patients at high risk for EAC who could benefit from surveillance and early endoscopic therapy, which in turn may lower EAC mortality. Upper endoscopy is the only means to diagnose BE, yet widespread endoscopic screening is impractical and expensive. There is an urgent need to develop minimally-invasive methods of BE screening that can be easily performed in the primary care setting to allow for efficient and cost-effective interventions to decrease EAC mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytosponge Test | Other | This arm will include individuals without formal diagnosis of Barrett's esophagus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytosponge | Device | The Cytosponge consists of a 3cm diameter, polyester, medical grade spherical sponge on a string, compressed within a gelatin capsule. The capsule is swallowed while the patient or the research specialist holds onto the string. After 3-5 minutes the gelatin capsule dissolves allowing the spherical sponge to expand. The sponge is then retrieved by gently pulling on the string, thus collecting cells along the passageway through the entire length of the esophagus. The sample is then put into a preservative to be processed for immunohistochemical testing for trefoil factor 3 (TFF3) to determine diagnosis of Barrett's esophagus. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation Rate | Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing. | 1 Day |
| Patient Tolerability Determined by Score on Likert Scale | After undergoing the Cytosponge test, subjects will be asked to take a "Cytosponge Post-Procedure Questionnaire" to assess tolerability using a Likert scale from 1 (no discomfort) to 10 (severe discomfort) and whether they would be willing to undergo Cytosponge testing again (yes/no). The scale for each question is rated 1 to 10. Lower scores are "better" (greater tolerability for that particular measure), higher scores are "worse" (less tolerable for that particular measure). Each question on the questionnaire will be assessed independently (i.e. one score per question). No total scores are calculated. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) | The PPV is the proportion of patients with endoscopic and histologic evidence of Barrett's esophagus on upper endoscopy from the total number of patients with TFF3-positive Cytosponge test who undergo a follow up endoscopy. | 1 Day |
| Number of Adverse Events (AEs) |
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Inclusion Criteria:
Males:
Ages 50-75 and at least one of the following:
Females:
Ages 50-75 and GERD* and at least one of the following:
Exclusion Criteria:
GERD defined as either a history of frequent heartburn or fluid regurgitation symptoms (at least weekly for 6 months) or regular use of proton pump inhibitors or histamine-2 receptor antagonists.
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| Name | Affiliation | Role |
|---|---|---|
| Julian Abrams, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cytosponge Test | This arm will include individuals without formal diagnosis of Barrett's esophagus. Cytosponge: The Cytosponge consists of a 3cm diameter, polyester, medical grade spherical sponge on a string, compressed within a gelatin capsule. The capsule is swallowed while the patient or the research specialist holds onto the string. After 3-5 minutes the gelatin capsule dissolves allowing the spherical sponge to expand. The sponge is then retrieved by gently pulling on the string, thus collecting cells along the passageway through the entire length of the esophagus. The sample is then put into a preservative to be processed for immunohistochemical testing for trefoil factor 3 (TFF3) to determine diagnosis of Barrett's esophagus. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cytosponge Test | This arm will include individuals without formal diagnosis of Barrett's esophagus. Cytosponge: The Cytosponge consists of a 3cm diameter, polyester, medical grade spherical sponge on a string, compressed within a gelatin capsule. The capsule is swallowed while the patient or the research specialist holds onto the string. After 3-5 minutes the gelatin capsule dissolves allowing the spherical sponge to expand. The sponge is then retrieved by gently pulling on the string, thus collecting cells along the passageway through the entire length of the esophagus. The sample is then put into a preservative to be processed for immunohistochemical testing for trefoil factor 3 (TFF3) to determine diagnosis of Barrett's esophagus. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Participation Rate | Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing. | Posted | Number | percent of participants | 1 Day |
|
1 Day
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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 | Cytosponge Test | This arm will include individuals without formal diagnosis of Barrett's esophagus. Cytosponge: The Cytosponge consists of a 3cm diameter, polyester, medical grade spherical sponge on a string, compressed within a gelatin capsule. The capsule is swallowed while the patient or the research specialist holds onto the string. After 3-5 minutes the gelatin capsule dissolves allowing the spherical sponge to expand. The sponge is then retrieved by gently pulling on the string, thus collecting cells along the passageway through the entire length of the esophagus. The sample is then put into a preservative to be processed for immunohistochemical testing for trefoil factor 3 (TFF3) to determine diagnosis of Barrett's esophagus. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julian Abrams, MD, MPH | Columbia University | 212-305-1909 | ja660@cumc.columbia.edu |
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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 | Nov 30, 2022 | Oct 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| C562730 | Adenocarcinoma Of Esophagus |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
Total number of all AEs related to Cytosponge testing |
| 1 Day |
| Number of Serious Adverse Events (SAEs) | Total number of all SAEs related to Cytosponge testing | 1 Day |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Patient Tolerability Determined by Score on Likert Scale | After undergoing the Cytosponge test, subjects will be asked to take a "Cytosponge Post-Procedure Questionnaire" to assess tolerability using a Likert scale from 1 (no discomfort) to 10 (severe discomfort) and whether they would be willing to undergo Cytosponge testing again (yes/no). The scale for each question is rated 1 to 10. Lower scores are "better" (greater tolerability for that particular measure), higher scores are "worse" (less tolerable for that particular measure). Each question on the questionnaire will be assessed independently (i.e. one score per question). No total scores are calculated. | Data was not collected due to study termination. | Posted | 1 Day |
|
|
| Secondary | Positive Predictive Value (PPV) | The PPV is the proportion of patients with endoscopic and histologic evidence of Barrett's esophagus on upper endoscopy from the total number of patients with TFF3-positive Cytosponge test who undergo a follow up endoscopy. | Data was not collected due to study termination. | Posted | 1 Day |
|
|
| Secondary | Number of Adverse Events (AEs) | Total number of all AEs related to Cytosponge testing | Posted | Number | study-related adverse events | 1 Day |
|
|
|
| Secondary | Number of Serious Adverse Events (SAEs) | Total number of all SAEs related to Cytosponge testing | Posted | Number | serious study-related adverse events | 1 Day |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 2 |
| 51 |
| Sore throat | General disorders | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |