Long-term saliva sampling for Barrett's esophagus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to evaluate the effectiveness of repeated saliva sampling to identify a microbiome signature associated with Barrett's esophagus (BE). Participants will be selected from patients who have undergone an endoscopy in the past three years. The study will assess whether the oral microbiome can serve as a reliable, non-invasive diagnostic tool for BE, which is a precursor to esophageal cancer. By analyzing saliva samples over time, the researchers hope to determine the stability and reproducibility of the microbiome signature in individuals diagnosed with BE.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Julian Abrams, MD — Columbia University
• Study coordinator: Julian Abrams, MD
• Email: ja660@cumc.columbia.edu
• Phone: 212-305-1909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.