RecruitingNCT05133102
Longitudinal Oral Microbiome Sampling for BE
Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
Sponsor
Columbia University
Enrollment
275 participants
Start Date
Mar 19, 2021
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria5
- 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
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Interventions
OTHERSample collection
Collection of saliva sample
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05133102
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