Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Columbia University
- Enrollment
- 275
- Locations
- 2
- Primary Endpoint
- Performance characteristics of a microbiome-based classifier with repeated sampling
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
Patients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus.
Intervention: Sample collection (Other)
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).
Intervention: Sample collection (Other)
Outcomes
Primary Outcomes
Performance characteristics of a microbiome-based classifier with repeated sampling
Time Frame: 2 months
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.
Intra-class correlation coefficients (ICC) by BE status
Time Frame: 2 months
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Julian A Abrams, MD
Associate Professor of Medicine and Epidemiology
Columbia University