An interventional study of Endoscopic Eradication Therapy in Barretts Esophagus With Dysplasia, Barrett Esophagus and Esophageal Adenocarcinoma, sponsored by University of Colorado, Denver. Recruiting at 30 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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 8th largest by planned enrollment of the 122 interventional ones that give a count, is one of 9 that started in 2023, is one of 78 with no phase, reaches primary completion later than 42 of the 47 other live ones, and was the 190th registered.
312 studies on the registry are indexed under Barrett Esophagus; 60 are open to participants now.
This study's planned enrollment of 680 is above the median of 62 across 187 interventional 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 to 89 Years · 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. 9 started in 2023.
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:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 6 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:
The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy.
To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells.
Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments.
While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other.
Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia.
This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data.
Methodology:
Patients with Barrett's esophagus and low grade dysplasia will be recruited in the multicenter trial. Patients will be randomized into endoscopic eradication therapy or endoscopic surveillance.
Subjects in the randomized control trial and observational cohort study, undergoing surveillance endoscopy will undergo surveillance biopsies in a 4-quadrant fashion every 1 cm throughout the extent of the Barrett's Esophagus using the Seattle biopsy protocol, along with targeted biopsies from any visible lesions. For incident low grade dysplasia (newly diagnosed low grade dysplasia - within 12 months of enrollment), surveillance endoscopies will be performed every 6 months for the first year and then annually until the end of the study period. For prevalent low grade dysplasia (diagnosed >1 year prior to enrollment), surveillance endoscopies will be performed annually until the end of the study period. The number of evaluations will depend on a subject's enrollment time with a maximum follow up period of 4years.
Subjects undergoing endoscopic eradication therapy will undergo radiofrequency ablation every 2-3 months until complete eradication of intestinal metaplasia (CE-IM) is achieved or 5 treatments have been delivered, whichever is first. After achieving CE-IM, surveillance endoscopy will performed every 6 months for the first year and annually thereafter until the end of the study period. Surveillance biopsies will be obtained using a standardized protocol.
Subjects will be contacted 48-72 hours and 30 days post procedure. All subjects will also receive follow-up phone calls on a semi-annual basis by a blinded central study coordinator.
Study Centers:
To maximize the generalizability of results, this randomized controlled trial will be conducted across different practice settings that include tertiary care centers, closed healthcare networks and large community practices at approximately 21 sites.
Anticipated Number of Participants:
680
Statistical Methodology:
Sample size and power calculations were performed for the primary endpoint using a time-to-event analysis. Estimates from available published data were used to approximate the expected progression rates in each arm of the trial. Based on previous clinical trials using similar methodology to confirm diagnosis of low grade dysplasia by expert pathology review, the team estimates 15% of patients with low grade dysplasia would progress to the composite primary endpoint in the surveillance arm compared to 6% in the endoscopic eradication therapy arm. T plan to accrue subjects for 3.5 years and follow them over time and record their time until progression to the primary endpoint or their censoring time if they do not progress. Follow-up observation will continue for approximately 1 year after the last subject is enrolled. Using this term of follow-up and assuming an exponential survival curve in each group and one interim analysis for efficacy and futility, 213 subjects are needed for analysis in each group to achieve 80% power using a two-sided 0.05 alpha level. Thus, accounting for a 10% non-adherence rate (attrition, subject cross-over) the team plans to enroll and randomize a total of 530 subjects (265 per study arm) who meet the eligibility criteria. A conservative rate of progression has been utilized for this sample size calculation given the significant heterogeneity in progression rates in the published literature. Recognizing that sample size estimation is based on assumptions and if the assumed event rate is lower than expected, there may be a decrease in power. To reduce the likelihood of an underpowered study due to incorrect assumptions, it is proposed to conduct a blinded sample size re-estimation once approximately 40% of the required events are reached.
All randomized subjects who are not identified at the index endoscopy with high grade dysplasia or post-endoscopy esophageal adenocarcinoma are defined as the intention to treat (ITT) population. The time to progression will be calculated from the time of randomization until the endoscopy date on which high grade dysplasia/mucosal post-endoscopy esophageal adenocarcinoma/invasive post-endoscopy esophageal adenocarcinoma is detected. If progression never occurs then the total time the subject is followed will be used as a censoring time. Time until censoring or progression to the primary endpoint of surveillance versus endoscopic eradication therapy will be compared by a log-rank test if the proportional hazards assumption is not violated. The continuous measures of Barrett's esophagus length will be included in the primary model as an independent variable. For all pre-specified analyses, a final two-sided p\<0.05 will indicate statistical significance. This study is powered to test the primary hypothesis. However, it also offers the opportunity to conduct several analyses addressing other important patient outcomes. Analyses will be conducted to identify risk factors of progression, as well as factors associated with subsequent absence of low grade dysplasia during follow-up using logistic regression analyses. Potential confounding baseline variables, such as demographics, presence of visible lesions, confirmed low grade dysplasia, multifocal low grade dysplasia, and center differences, will be examined.
Inclusion Criteria: Any patient with Barrett's esophagus and low grade dysplasia who provides AND:
Meets all the following criteria will be eligible for enrollment:
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.
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 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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in the randomized control trial and observational cohort study, undergoing surveillance endoscopy will undergo surveillance biopsies in a 4-quadrant fashion every 1 cm throughout the extent of the Barrett's esophagus using the Seattle biopsy protocol, along with targeted biopsies from any visible lesions. For incident low grade dysplasia (newly diagnosed low grade dysplasia - within 12 months of enrollment), surveillance endoscopies will be performed every 6 months for the first year and then annually until the end of the study period. For prevalent low grade dysplasia (diagnosed \>1 year prior to enrollment), surveillance endoscopies will be performed annually until the end of the study period. The number of evaluations will depend on a subject's enrollment time.
Subjects undergoing endoscopic eradication therapy will undergo radiofrequency ablation every 2-3 months until complete eradication of intestinal metaplasia (CE-IM) is achieved or 5 treatments have been delivered, whichever is first. After achieving CE-IM, surveillance endoscopy will performed every 6 months for the first year and annually thereafter until the end of the study period. Surveillance biopsies will be obtained using a standardized protocol.
Procedure: Endoscopic Eradication Therapy
Endoscopic eradication therapy is a procedure performed to destroy the precancerous cells at the bottom of your esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures are performed through the endoscope.
Neoplastic Progression
The occurrence of high grade dysplasia/mucosal post-endoscopy esophageal adenocarcinoma/invasive post-endoscopy esophageal adenocarcinoma at any time during the study period following enrollment.
Time frame: Baseline, through study completion
Work Productivity and Activity
The Work Productivity and Activity Index (WPAI) is a 6-item questionnaire that has been adapted to address the impact of reflux symptoms on work and activity burden. Patient-centered outcomes (PCOs) have been defined and prioritized by key stakeholders (patients, caregivers, clinicians) and will be compared in Barrett's esophagus patients with low grade dysplasia treated with endoscopic eradication therapy to those undergoing surveillance.
Time frame: Baseline, through study completion
Biomarker Utility
Three biomarkers of interest (p53, TissueCypher and WATS3D) will be collected to examine the relationship between biomarker results and the primary efficacy outcome.
Time frame: Baseline, through study completion
Esophageal Adenocarcinoma (EAC) progression rate
The proportion of subjects that progress to a diagnosis of invasive post-endoscopy esophageal adenocarcinoma alone during follow up
Time frame: Baseline, through study completion
Patient-Reported Depression, Anxiety, and Gastrointestinal Symptoms
NIH PROMIS measures (fixed, short-forms) will be used to measure the following constructs: Depression (4 items), Anxiety (8 items), Gastrointestinal Symptoms (13 items dedicated to GERD) and Global Health (10 items). Patient-centered outcomes (PCOs) have been defined and prioritized by key stakeholders (patients, caregivers, clinicians) and will be compared in Barrett's esophagus patients with low grade dysplasia treated with endoscopic eradication therapy to those undergoing surveillance.
Time frame: Baseline, through study completion
Patient-Reported Gastroesophageal Reflux
The Gastroesophageal Reflux Questionnaire (GERD-Q; 6 items) will assess severity of reflux symptoms including chest pain, burning, and regurgitation. Patient-centered outcomes (PCOs) have been defined and prioritized by key stakeholders (patients, caregivers, clinicians) and will be compared in Barrett's esophagus patients with low grade dysplasia treated with endoscopic eradication therapy to those undergoing surveillance.
Time frame: Baseline, through study completion
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Started Jan 2023 (actual). Primary completion is estimated for Apr 2029, 75 months after the start.
Of 65 non-industry interventional studies with no phase under Barrett Esophagus, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 108. This study's planned 75 months is above that.
Counting every sponsor, half of 76 studies reached it within 45 months; a quarter within 23 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
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University of Colorado, Denver →