An observational study in Barrett's Esophagus With Dysplasia, sponsored by Columbia University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Columbia University · Observational
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 79th largest by planned enrollment of the 86 observational ones that give a count, is one of 6 that started in 2026, is one of 87 observational ones, reaches primary completion later than 21 of the 47 other live ones, and was the 207th registered.
312 studies on the registry are indexed under Barrett Esophagus; 60 are open to participants now.
This study's planned enrollment of 15 is below the median of 144 across 118 observational studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →38 of the 209 studies in Barrett Esophagus with a site in United States are open now, in 2 countries. Each count lists the studies.
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: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →209 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 6 started in 2026.
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.
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 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Columbia University has 7 studies filed under Barrett Esophagus — fewer than ten, so there is no comparison to draw.
14 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 |
| NCT00590239Midwest Biomedical Research FoundationBarrett's Esophagus Related Neoplasia (BERN) Project | 2026-11-01 |
| 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 |
Among the 209 studies in Barrett Esophagus with a site in United States, from their registry updates:
Barrett's esophagus (BE) is a condition in which the normal lining of the esophagus is replaced by abnormal tissue that can increase the risk of esophageal cancer. Endoscopic eradication therapy (EET) removes this abnormal tissue, but most patients need several treatment sessions, leading to higher costs, inconvenience, and cumulative risk. Research suggests that bile reflux, especially a bile acid called deoxycholic acid (DCA), may interfere with healing after treatment by promoting regrowth of Barrett's tissue. Ursodeoxycholic acid (UDCA), an FDA-approved medication used for certain liver and gallbladder conditions, lowers harmful bile acids and may help the normal esophageal lining grow back more effectively. In this pilot study, patients undergoing endoscopic treatment and taking UDCA will be followed to see whether UDCA treatment improves healing and reduces the number of procedures needed. If successful, this approach could lower costs, decrease risks, and make treatment more accessible for patients at risk of esophageal cancer.
Patients with Barrett's esophagus (BE) and low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal adenocarcinoma undergoing endoscopic eradication therapy who are taking ursodeoxycholic acid (UDCA).
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.
Either one of the following:
Exclusion Criteria:
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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 authorised 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.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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 authorised 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.
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.
Patients with Barrett's esophagus-associated neoplasia who are being treated with UDCA and are undergoing endoscopic eradication therapy
Percent Neosquamous Regrowth (PNR) after a single treatment session
At each endoscopy, photos will be taken starting at the GE junction and every 1 cm along the original length of BE. Three independent reviewers (the PI and two collaborators) will score the percent neosquamous regrowth based on the photo images comparing the baseline and follow-up endoscopy, with each reviewer blinded to the other reviewers' scores. PNR estimates will be made in increments of 5% (5%, 10%, 15%, etc.). The mean of the three reviewer's assessments will serve as the final PNR for each subject. We will then calculate the mean PNR with associated 95% CI for the study population.
Time frame: Baseline endoscopy to first follow-up endoscopy at approx. 2 months +/- 4 weeks
Effects of UDCA on refluxate bile acid composition
Within-individual change in total deoxycholic acids (DCAs) will be assessed and reported as median and interquartile range. Total DCAs will be calculated as the sum of the unconjugated and conjugated forms of DCA (DCA, glyco-DCA, tauro-DCA).
Time frame: Baseline endoscopy until complete eradication of BE or after 4 treatments (approximately 8-10 months)
Number of treatment sessions required to achieve complete eradication of BE
Investigators will calculate the proportion of patients requiring ≤3 ablation treatments to achieve complete eradication of Barrett's Esophagus (CE-BE). Median and IQR will be calculated for the number of treatment sessions required to achieve CE-BE.
Time frame: Baseline endoscopy until complete eradication of BE or after 4 treatments (approximately 8-10 months)
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 40 observational studies under Barrett Esophagus, half reached primary completion within 252 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 252. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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