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RECRUITINGOBSERVATIONAL

Longitudinal Oral Microbiome Sampling for BE

Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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