findmyKOL
Clinical trialNCT05530343RecruitingInterventional

Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance

SponsorUniversity of Colorado, DenverEnrollment2,298Barrett EsophagusBarretts Esophagus With DysplasiaEsophageal Adenocarcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D). Barrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer. Endoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a 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. Patients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD). Patients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE. While both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other. Participants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized. Up to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Arizona Centers of Digestive Health

    Gilbert, Arizona, United States

    Mankanwal Sachdev, MDVirender Sharma, MD
    Recruiting
  • Ucla / Jonsson Comprehensive Cancer Center

    Los Angeles, California, United States

    Adarsh M Thaker, MDKevin A Ghassemi, MDVenkataraman Muthusamy, MD
    Recruiting
  • Kaiser Permanente

    Oakland, California, United States

    Gene Ma, MDHoward Chang, MDMitchell Liverant, MD
    Recruiting
  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, United States

    Mihir Wagh, MDPaul Menard-Katcher, MDSachin Wani, MDSteven Edmundowicz, MD
    Recruiting
  • Connecticut Clinical Research Institute

    Bristol, Connecticut, United States

    Daniel Smiley, MDDavid Chaletsky, MDEddy Castillo, MDLiam Zakko, MDMark Versland, MDPeter Bloom, MDSalam Zakko, MD
    Recruiting
  • Suncoast Endoscopy of Sarasota

    Sarasota, Florida, United States

    Scott Corbett, MD
    Recruiting
  • Northwestern University

    Chicago, Illinois, United States

    Srinadh Komanduri, MD
    Recruiting
  • Mayo Clinic

    Rochester, Minnesota, United States

    Cadman Leggett, MDChamil Codipilly, MDPrasad Iyer, MD
    Recruiting
  • Long Island Jewish Medical Center

    New Hyde Park, New York, United States

    Arvind Trindade, MD
    Recruiting
  • Weill Cornell Medicine

    New York, New York, United States

    Amir Soumekh, MDFelice H Schnoll-Sussman, MDPhilip O Katz, MD
    Recruiting
  • University of Rochester

    Rochester, New York, United States

    Shivangi Kothari, MDVivek Kaul, MD
    Recruiting
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, United States

    Cary C Cotton, MDNicholas J Shaheen, MDSwathi Eluri, MD
    Recruiting
  • Geisinger Medical Center

    Danville, Pennsylvania, United States

    Harshit Khara, MDJoshua Obuch, MD
    Recruiting
  • Gastrointestinal Associates, Pc

    Knoxville, Tennessee, United States

    John M Haydek, MDRaj I Narayani, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
3 Oct 2022
Primary completion
30 Jun 2026
Completion
30 Jun 2026
Last update posted
1 Jul 2026
Registered enrollment
2,298
Registry id
NCT05530343

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.