Long-term saliva sampling for Barrett's esophagus
Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
This study is testing if regular saliva samples can help identify a specific oral bacteria pattern in people with Barrett's esophagus to see if it can be used as a simple way to diagnose this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 275 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT05133102 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for or have had an upper endoscopy within the last three years and have been diagnosed with Barrett's esophagus.
Not a fit: Patients with a history of head and neck cancer, esophageal squamous cell or gastric cancer, or those who have undergone certain types of esophageal or gastric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for diagnosing and monitoring Barrett's esophagus, potentially reducing the need for invasive endoscopic procedures.
How similar studies have performed: While the approach of using saliva microbiome analysis is relatively novel, previous studies have indicated distinct microbiome profiles in patients with Barrett's esophagus, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.