RecruitingNCT05133102

Longitudinal Oral Microbiome Sampling for BE

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


Sponsor

Columbia University

Enrollment

275 participants

Start Date

Mar 19, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

OTHERSample 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

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NCT05133102


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