Longitudinal Oral Microbiome Sampling for BE

NCT05133102 | Recruiting

• 2 other identifiers: AAAS2622R01CA238433
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 2

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.

Conditions

Barrett Esophagus

Keywords

Saliva; Sampling; Oral Microbiome

Outcome Measures

Primary Outcomes (2)

• Performance characteristics of a microbiome-based classifier with repeated sampling

  Using a classifier developed from 16S rRNA gene sequencing data, the investigators will calculate the area under the receiver operating curve (AUROC) and associated 95% confidence interval for a classifier with three repeated measures per subject.

  2 months

• Intra-class correlation coefficients (ICC) by BE status

  This will be measured to determine the degree of consistency of a microbiome-based classifier for each individual's salivary microbiome assessments (three total per subject).

  2 months

Study Arms (2)

Control

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

Other: Sample collection

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).

Other: Sample collection

Interventions

Sample collection OTHER

Collection of saliva sample

Barrett's Esophagus; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrollment will continue until a total of 250 subjects complete all three saliva specimen collections: * 50 BE patients * 200 controls The investigators anticipate that approximately 10% of subjects will not complete all three specimen collections and will be excluded from the primary outcome analyses. Thus, the investigators expect to enroll \~275 subjects to have 250 with three saliva specimen collections. There is no cap on enrollment per study site. The anticipated duration of enrollment is 2 years (24 months).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• University of Michigan: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Julian Abrams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Abrams, MD

CONTACT

212-305-1909; ja660@cumc.columbia.edu

Katharine Boyce, RN

CONTACT

kb3217@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: March 19, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)