Longitudinal Oral Microbiome Sampling for BE

Columbia University

Status: Enrolling

Conditions: Barrett Esophagus

Treatments: Other: Sample collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05133102

AAAS2622

R01CA238433 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Saliva collection is non-invasive and can be performed in clinical and non-clinical settings. As such, saliva testing is a highly attractive method for diagnosing and/or monitoring disease. The investigators previously showed that the bacterial make-up ("microbiome") of saliva is highly distinct in patients with and without Barrett's esophagus (BE), a precursor to esophageal cancer that normally can only be diagnosed by undergoing an upper endoscopy. While the microbiome of saliva is felt to be relatively stable over time, it is unclear whether a microbiome signature for Barrett's esophagus is reproducible within individuals. Also, repeated testing of saliva may improve the ability to diagnose Barrett's esophagus.

Enrollment: 275 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

275 participants in 2 patient groups

Control

Description:

Patients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus.

Treatment:

Other: Sample collection

Barrett's Esophagus

Description:

Patients who have undergone an endoscopy within the last three years and have histologically confirmed Barrett's esophagus. BE segment must be M\>1cm, and has not be treated with endoscopic eradication therapy (focal mucosal resection without subsequent eradication therapy is allowed).

Treatment:

Other: Sample collection