Utility Of Mutational Load As A Predictor For Endoscopic Treatment Response In Barrett's Esophagus
Barretts Esophagus With Dysplasia, Intramucosal Adenocarcinoma
About this trial
This is an interventional basic science trial for Barretts Esophagus With Dysplasia
Eligibility Criteria
Inclusion Criteria:
- No prior history of endoscopic treatment therapy for BE
Previously untreated "treatment naïve" disease history with confirmed histopathology analysis of at least one of the following:
- Low- or high-grade dysplastic BE (history of endoscopic mucosal resection (EMR)) is allowable or
- Intramucosal adenocarcinoma (IMC)
- BE lesion length of at least: C0, M1
- At least 18 years of age at time of consent
- Able and willing to provide written informed consent
- Able and willing to comply with required study procedures and follow-up schedule
Exclusion Criteria:
- History of endoscopic intervention for the treatment of gastroesophageal reflux disease (GERD), BE, or IMC (prior EMR is allowable)
- Current esophageal stenosis/stricture preventing advancement of a therapeutic scope or significant esophageal anatomic abnormalities (masses, obstructive lesions, etc.)
- Dysplasia of intestinal metaplasia (IM) confined only to the gastric cardia (BE Prague Criteria: C0M0)
- Uncontrolled coagulopathy
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- Known portal hypertension, visible esophageal varices, or history of esophageal varices
- Previous esophagectomy surgery involving the gastroesophageal junction (history of a fundoplication is OK)
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
- Subject has any condition that, in the opinion of the investigator or sponsor, would interfere with accurate interpretation of the study endpoints or preclude participation in the trial
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Other
Biopsy: Barrett's Esophagus, Intramucosal adenocarcinoma
Subjects will undergo standard of care (SOC) standard esophagogastroduodenoscopy (EGD) for the treatment of their condition (BE or IMC). Four (4) research biopsies will be taken from the midpoint of current disease. In cases where EMR (Endoscopic Mucosal Resection) is performed clinically, no research biopsies will be taken. Following CEIM, four (4) additional research biopsies will be collected, from the midpoint of previous BE site. Laboratory Biomarker Analysis: Correlative studies Esophagogastroduodenoscopy: Standard of care, research biopsies will be collected if clinical biopsies are taken