Basic Study Information
Purpose:Location: University of Rochester
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
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.
Lead Researcher (Principal Investigator)
Study Contact Information
Study Contact: Clinical Trials Office
Study Location: Wilmot Cancer Institute, University of Rochester Medical Center
Study Email: WCICTOResearch@urmc.rochester.edu
Additional Study Details
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