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Longitudinal Oral Microbiome Sampling for BE
RECRUITINGSponsored by Columbia University
Actively Recruiting
SponsorColumbia University
Started2021-03-19
Est. completion2026-08
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05133102
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
Barrett EsophagusCancer
Locations2 sites
Michigan
1 siteNew York
1 siteColumbia University Irving Medical Center
New York, New York, 10032
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Actively Recruiting
SponsorColumbia University
Started2021-03-19
Est. completion2026-08
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05133102