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Major trial aims to settle best approach for precancerous esophagus condition

NCT ID NCT05753748

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study compares two standard approaches for Barrett's esophagus with low-grade dysplasia: regular monitoring with biopsies (surveillance) versus a procedure to remove or burn away precancerous cells (endoscopic eradication therapy). Researchers want to find out which method is safer and more effective at preventing progression to cancer. About 680 adults with this condition will take part across multiple U.S. hospitals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endoscopic eradication therapy (removal or burning of precancerous cells) and endoscopic surveillance (biopsy monitoring)
What this could lead to
If successful, this trial could show that one approach is safer and more effective at preventing esophageal cancer in people with Barrett's esophagus and low-grade dysplasia.
What could go wrong
This is a large, well-designed trial, but low-grade dysplasia often does not progress to cancer, so the benefit of aggressive treatment may be small. Endoscopic therapy also carries risks like bleeding or narrowing of the esophagus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 680 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND: Meets all the following criteria will be eligible for enrollment: 1. Male or female, age ≥18 years; 2. Subject has endoscopic evidence of Barrett's esophagus characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas demonstrating columnar metaplasia with goblet cells. This inclusion criterion will exclude patients with intestinal metaplasia with dysplasia of the gastric cardia; 3. Biopsies within the previous 12 months demonstrating Barrett's esophagus and indeterminate for dysplasia or low grade dysplasia; 4. Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months; 5. Demonstrated ability to tolerate proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) therapy based on patient self-report; and, 6. Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures. Exclusion Criteria: 1. Pregnancy; 2. Prior endoscopic eradication therapy for Barrett's esophagus; 3. History of high grade dysplasia or esophageal adenocarcinoma; 4. History of esophageal resection/esophagectomy 5. Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis; 6. Esophageal strictures precluding passage of the endoscope or treatment catheters - patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy; 7. Esophageal varices or known portal hypertension; and 8. Life expectancy of \<2 years as judged by the site investigator. \* Patients are eligible for enrollment and randomization if they meet the above eligibility criteria. It should be noted that the presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion. Those with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology. If HGD or EAC pathology is determined, then the subject will exit from the study after a 30-day safety follow up

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus Barrett esophagus esophageal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Barrett esophagus Barretts esophagus with dysplasia Esophageal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland VA Medical Research and Education Foundation

    RECRUITING

    Cleveland, Ohio, 35294, United States

  • Columbia Universtiy

    RECRUITING

    New York, New York, 10032, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Florida Digestive Health Specialists

    TERMINATED

    Sarasota, Florida, 34239, United States

  • Indiana University Melvin & Bren Simon Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins Universtiy

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Kaiser Permanente

    RECRUITING

    San Jose, California, 95119, United States

  • Kaiser Permanente Oakland Medical Center

    RECRUITING

    Oakland, California, 94611, United States

  • Long Island Jewish Medical Center

    RECRUITING

    Manhasset, New York, 11030, United States

  • Mayo Clinic

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Parkview Research Center

    TERMINATED

    Fort Wayne, Indiana, 46845, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University Hospitals Cleveland Medical Center Case Western University

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35924, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina School of Medicine

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylania, Perelman School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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