RECRUITINGOBSERVATIONAL
Longitudinal Oral Microbiome Sampling for BE
Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
About This Trial
This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years.
Who May Be Eligible (Plain English)
Who May Qualify:
- Scheduled for an upper endoscopy or had upper endoscopy within past three years
- Eighteen years of age or older
- Capable of producing a saliva sample
- Able to give willing to sign a consent form
- For BE patients only: Endoscopic evidence of Barrett's esophagus (at least 1 cm maximal BE length; i.e. Prague classification: any C, M≥1), and intestinal metaplasia present on esophageal biopsies
Who Should NOT Join This Trial:
- History of head and neck cancer or esophageal squamous cell or gastric cancer
- History of esophageal or gastric surgery
- Scheduled to undergo colonoscopy on the day of initial saliva collection
- Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection
- For BE patients only: History of prior endoscopic therapy for BE except a history of prior Endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Scheduled for an upper endoscopy or had upper endoscopy within past three years
* Eighteen years of age or older
* Capable of producing a saliva sample
* Able to give informed consent
* For BE patients only: Endoscopic evidence of Barrett's esophagus (at least 1 cm maximal BE length; i.e. Prague classification: any C, M≥1), and intestinal metaplasia present on esophageal biopsies
Exclusion Criteria:
* History of head and neck cancer or esophageal squamous cell or gastric cancer
* History of esophageal or gastric surgery
* Scheduled to undergo colonoscopy on the day of initial saliva collection
* Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection
* For BE patients only: History of prior endoscopic therapy for BE except a history of prior Endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted
Treatments Being Tested
OTHER
Sample collection
Collection of saliva sample
Locations (2)
University of Michigan
Ann Arbor, Michigan, United States
Columbia University Irving Medical Center
New York, New York, United States