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Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett

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 patie

Condition(s)Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophageal Adenocarcinoma
StatusRecruiting
PhaseNA
Study typeInterventional
SummaryThe 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 a
Who can participateInclusion 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
Ages18 Years to 89 Years
SexAll
Lead sponsorUniversity of Colorado, Denver
LocationsGilbert, Arizona, United States; Los Angeles, California, United States; Oakland, California, United States; Aurora, Colorado, United States; Bristol, Connecticut, United States; Sarasota, Florida, United States (+8 more sites)
Start date2022-10-03
NCT IDNCT05530343
Official listinghttps://clinicaltrials.gov/study/NCT05530343

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