RECRUITING

Longitudinal Oral Microbiome Sampling for BE

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Conditions

Barrett EsophagusSalivaSamplingOral Microbiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus

Quick Facts

Study Start:2021-03-19
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05133102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Scheduled for an upper endoscopy or had upper endoscopy within past three years
  2. * Eighteen years of age or older
  3. * Capable of producing a saliva sample
  4. * Able to give informed consent
  5. * 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
  1. * History of head and neck cancer or esophageal squamous cell or gastric cancer
  2. * History of esophageal or gastric surgery
  3. * Scheduled to undergo colonoscopy on the day of initial saliva collection
  4. * Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection
  5. * 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

Contacts and Locations

Study Contact

Julian Abrams, MD
CONTACT
212-305-1909
ja660@cumc.columbia.edu
Katharine Boyce, RN
CONTACT
kb3217@cumc.columbia.edu

Principal Investigator

Julian Abrams, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Julian Abrams, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-19
Study Completion Date2025-08

Study Record Updates

Study Start Date2021-03-19
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Saliva
  • Sampling
  • Oral Microbiome

Additional Relevant MeSH Terms

  • Barrett Esophagus