Status:
COMPLETED
Utility Of Mutational Load As A Predictor For Endoscopic Treatment Response In Barrett's Esophagus
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Interpace Diagnostics Corporation
Conditions:
Barretts Esophagus With Dysplasia
Intramucosal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate association between mutational load (ML) from esophageal biopsy specimens in pre-endoscopic eradication therapy (EET) in Barrett's Esophagus (BE) or Intramucosal adenocarcinoma (IMC) patie...
Detailed Description
Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained, subjects will co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04316975
Start Date
April 10 2020
End Date
December 20 2023
Last Update
April 8 2024
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599