Utility Of Mutational Load As A Predictor For Endoscopic Treatment Response In Barrett's Esophagus (NCT04316975) | Clinical Trial Compass
CompletedNot Applicable
Utility Of Mutational Load As A Predictor For Endoscopic Treatment Response In Barrett's Esophagus
United States75 participantsStarted 2020-04-10
Plain-language 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) patients and treatment resistance (treatment resistance will be defined as disease recurrence and/or need for additional intervention such as increased acid suppression, need for anti-reflux surgery, or use of alternate ablative modality).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Subjec…
What they're measuring
1
Correlation of Mean Mutational Load (ML) and Treatment Resistance