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

RecruitingNAAges 18 Years - 89 YearsAllUniversity of Colorado, Denver
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In plain words

What the trial is, and whether it could suit you

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 developin

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Seattle protocol
  • WATS3D brushings
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Where

14 sites
Arizona Centers of Digestive Health
Gilbert, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, United States
Kaiser Permanente
Oakland, United States
University of Colorado Anschutz Medical Campus
Aurora, United States
Connecticut Clinical Research Institute
Bristol, United States
Suncoast Endoscopy of Sarasota
Sarasota, United States
Northwestern University
Chicago, United States
Mayo Clinic
Rochester, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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