NCT05133102 · Columbia University
Longitudinal Oral Microbiome Sampling for BE
What this study is about
This is a longitudinal group of participants study to assess the impact of repeated sampling of an taken by mouth 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.
View original scientific 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.
Interventions
OTHER
Sample collection
Collection of saliva sample
Primary outcome measures
Performance characteristics of a microbiome-based classifier with repeated sampling
Time frame: 2 months
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.
Intra-class correlation coefficients (ICC) by BE status
Time frame: 2 months
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
- New York, New York
Collaborators
University of Michigan, National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations