Longitudinal Oral Microbiome Sampling for BE

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133102
• Other study ID #: AAAS2622
• Secondary ID: R01CA238433
• Status: Recruiting
• Start date: March 19, 2021
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: Julian Abrams, MD
• Phone: 212-305-1909
• Email: ja660[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Other:
• Sample collection
Collection of saliva sample

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	National Cancer Institute (NCI), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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