An interventional study of Cytosponge in Barrett Esophagus and Esophageal Adenocarcinoma, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Columbia University · Not applicable, Interventional, and Screening
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Among 209 studies in Barrett Esophagus with a site in United States — 38 open to participants now, 48 under way, none of them phase 3. Barrett Esophagus · United States.
Among the 209 studies in Barrett Esophagus with a site in United States, this one is the 66th largest by enrollment of the 122 interventional ones that give a count, is one of 7 that started in 2018, is one of 78 with no phase, and was the 149th registered.
312 studies on the registry are indexed under Barrett Esophagus; 60 are open to participants now.
Browse Barrett Esophagus studies →38 of the 209 studies in Barrett Esophagus with a site in United States are open now. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Cleveland VA Medical Research and Education Foundation · Sites in United States
Ages 40–85
Case Comprehensive Cancer Center · Sites in United States
Ages 50+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 44 Barrett Esophagus studies recruiting now, 31 (70%) set no upper age limit and 2 (5%) stop at 75 or younger; 4 take children under 18; 10 take healthy volunteers.
This study: 50 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
209 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 14 · Phase 3 3 · Phase 4 8
First in 2000; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 51 is below the median of 62 across 187 interventional studies indexed under Barrett Esophagus.
Median enrollment 58 across the 122 interventional studies, 123 across the 86 observational. Of the 141 that completed or were terminated, 45 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
37 of 209 have an industry lead sponsor. The 10 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 181 completed or terminated interventional studies of FDA-regulated products, 149 (82%) have results posted.
Columbia University has 7 studies filed under Barrett Esophagus — fewer than ten, so there is no comparison to draw.
13 of the studies in Barrett Esophagus with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532734Denver Health and Hospital AuthorityBarrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype | 2026-11 |
| NCT03316053The Guthrie ClinicCell Marker Predictors in Barrett's Esophagus | 2026-12-01 |
| NCT02634645University of Colorado, DenverTREAT-BE Study (Treatment with Resection and Endoscopic Ablation Techniques for Barrett's Esophagus) | 2027-01 |
| NCT05468008AdventHealthEndoscopic Submucosal Dissection (ESD) | 2027-02 |
| NCT05216133NYU Langone HealthBiomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN) | 2027-06 |
Add all 13 to your calendar (.ics) → With an account.
Among the 209 studies in Barrett Esophagus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will include individuals without formal diagnosis of Barrett's esophagus.
Device: 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.
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.
Time frame: 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.
Time frame: 1 Day
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.
Time frame: 1 Day
Number of Adverse Events (AEs)
Total number of all AEs related to Cytosponge testing
Time frame: 1 Day
Number of Serious Adverse Events (SAEs)
Total number of all SAEs related to Cytosponge testing
Time frame: 1 Day
| Milestone | Cytosponge Test |
|---|---|
| Started | 51 |
| Completed | 51 |
| Not completed | 0 |
Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.
| percent of participants | Cytosponge Test |
|---|---|
| Participation Rate | 58.6 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Total number of all AEs related to Cytosponge testing
| study-related adverse events | Cytosponge Test |
|---|---|
| Number of Adverse Events (AEs) | 0 |
Total number of all SAEs related to Cytosponge testing
| serious study-related adverse events | Cytosponge Test |
|---|---|
| Number of Serious Adverse Events (SAEs) | 0 |
Collected over 1 Day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cytosponge Test | 0/51 (0%) | 0/51 (0%) | 2/51 (3.9%) |
| Event | Cytosponge Test |
|---|---|
| FeverGeneral disorders | 1/51 |
| Sore throatGeneral disorders | 1/51 |
| Age, Continuous(years) | Cytosponge Test |
|---|---|
| Mean | 64 (50 to 74) |
| Sex: Female, Male(Participants) | Cytosponge Test |
|---|---|
| Female | 14 |
| Male | 37 |
| Race and Ethnicity Not Collected(Participants) | Cytosponge Test |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2018 to primary completion in May 2023, 57 months.
Results were first posted in Nov 2024, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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