Longitudinal Oral Microbiome Sampling for BE

ConditionBarrett Esophagus

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorColumbia University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Enrollment will continue until a total of 250 subjects complete all three saliva specimen collections: * 50 BE patients * 200 controls The investigators anticipate that approximately 10% of subjects will not complete all three specimen collections and will be excluded from the primary outcome analyses. Thus, the investigators expect to enroll \~275 subjects to have 250 with three saliva specimen collections. There is no cap on enrollment per study site. The anticipated duration of enrollment is 2 years (24 months).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Sample collection
Other intervention
Collection of saliva sample

Treatment groups

275 Participants

are divided into 2 treatment groups

Group A: Control1 intervention

Group B: Barrett's Esophagus1 intervention

Trial outcomes

Primary outcomes

Performance characteristics of a microbiome-based classifier with repeated sampling

Using a classifier developed from 16S rRNA gene sequencing data, the investigators will calculate the area under the receiver operating curve (AUROC) and associated 95% confidence interval for a classifier with three repeated measures per subject.

Time frame

2 months

Intra-class correlation coefficients (ICC) by BE status

This will be measured to determine the degree of consistency of a microbiome-based classifier for each individual's salivary microbiome assessments (three total per subject).

Time frame

2 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

University of Michigan

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

Apply now