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Which biopsy method best spots early esophageal cancer?

NCT ID NCT05530343

Diagnosis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial compares two ways to sample tissue in people with Barrett's esophagus, a condition that raises the risk of esophageal cancer. The standard method takes four small tissue samples every 2 centimeters, while the newer method uses a brush to collect cells over a wider area. The study aims to see which approach better detects precancerous changes or early cancer. About 2,300 participants will undergo both methods during endoscopy, with the order randomly assigned.

What this could mean

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

What this could lead to
If one method proves superior, it could become the new standard for detecting early esophageal cancer, potentially saving lives through earlier treatment.
What could go wrong
The trial compares two already accepted methods, so the difference may be small. Results depend on confirmation biopsies, and the benefit may not apply to all patients.

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 2,298 people

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

Started

Oct 2022

Expected to finish

Jun 2026

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: Surveillance Population * Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia/indefinite for dysplasia with NDBE at last endoscopy can be included) * Barrett's esophagus (BE) length of at least M1 * English and Spanish speaking * Able to comprehend and complete the consent form * Age18-89 years * Life-expectancy of at least 2 years Screening Population * Undergoing endoscopy for screening of BE * BE length of at least M1 * English and Spanish speaking * Able to comprehend and complete the consent form * Age 18-89 years * Expected life-expectancy of at least 2 years Physicians -All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study. Exclusion Criteria: Surveillance Population * BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC) * Active erosive esophagitis with LA Grade B or higher * Esophageal varices * Prior history of EET * Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication * Pregnancy Screening Population * BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC * Active erosive esophagitis with LA Grade B or higher * Esophageal varices * Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication * Pregnancy

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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

    14 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

  • Arizona Centers of Digestive Health

    RECRUITING

    Gilbert, Arizona, 85295, United States

  • Connecticut Clinical Research Institute

    RECRUITING

    Bristol, Connecticut, 06010, United States

  • Gastrointestinal Associates, PC

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

  • Kaiser Permanente

    RECRUITING

    Oakland, California, 94611, United States

  • Long Island Jewish Medical Center

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Suncoast Endoscopy of Sarasota

    RECRUITING

    Sarasota, Florida, 34239, United States

  • UCLA / Jonsson Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90024, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.