Longitudinal Oral Microbiome Sampling for BE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sample collection.
- Who it may be relevant to
- Registry conditions: Barrett Esophagus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
Overview
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.
Interventions
- Other Sample collection
Collection of saliva sample
Primary outcome measures
- Performance characteristics of a microbiome-based classifier with repeated sampling [Time frame: 2 months]
- Intra-class correlation coefficients (ICC) by BE status [Time frame: 2 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- University of Michigan — Ann Arbor
- Columbia University Irving Medical Center — New York
Identifiers
NCT: NCT05133102 · AAAS2622 · R01CA238433