NCT05133102 Longitudinal Oral Microbiome Sampling for BE
| NCT ID | NCT05133102 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Barrett Esophagus |
| Study Type | OBSERVATIONAL |
| Enrollment | 275 participants |
| Start Date | 2021-03-19 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 275 participants in total. It began in 2021-03-19 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Julian Abrams, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05133102 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Barrett Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05133102 currently recruiting?
Yes, NCT05133102 is actively recruiting participants. Contact the research team at ja660@cumc.columbia.edu for enrollment information.
Where is the NCT05133102 trial being conducted?
This trial is being conducted at Ann Arbor, United States, New York, United States.
Who is sponsoring the NCT05133102 clinical trial?
NCT05133102 is sponsored by Columbia University. The principal investigator is Julian Abrams, MD at Columbia University. The trial plans to enroll 275 participants.