Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05133102
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2021-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal Oral Microbiome Sampling for BE
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Saliva collection is non-invasive and can be performed in clinical and non-clinical settings. As such, saliva testing is a highly attractive method for diagnosing and/or monitoring disease. The investigators previously showed that the bacterial make-up ("microbiome") of saliva is highly distinct in patients with and without Barrett's esophagus (BE), a precursor to esophageal cancer that normally can only be diagnosed by undergoing an upper endoscopy. While the microbiome of saliva is felt to be relatively stable over time, it is unclear whether a microbiome signature for Barrett's esophagus is reproducible within individuals. Also, repeated testing of saliva may improve the ability to diagnose Barrett's esophagus.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA238433 | NIH | None | https://reporter.nih.gov/quic… | View |