Longitudinal Oral Microbiome Sampling for BE

NCT ID: NCT05133102

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 275 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2026-08-31

Brief 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.

Detailed 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.

Conditions

Barrett Esophagus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

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

Sample collection

Intervention Type: OTHER

Collection of saliva sample

Barrett's Esophagus

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).

Sample collection

Intervention Type: OTHER

Collection of saliva sample

Interventions

Sample collection

Collection of saliva sample

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Julian A Abrams, MD

Associate Professor of Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julian Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julian Abrams, MD

Role: CONTACT

ja660@cumc.columbia.edu

212-305-1909

Katharine Boyce, RN

Role: CONTACT

kb3217@cumc.columbia.edu

Facility Contacts

Joel H. Rubenstein, MD

Role: primary

jhr@med.umich.edu

Amy Liu

Role: backup

Liuyalie@med.umich.edu

Julian Abrams, MD

Role: primary

ja660@cumc.columbia.edu

212-305-1909

Other Identifiers

R01CA238433

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS2622

Identifier Type: -

Identifier Source: org_study_id