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NCT03060642 · ClinicalTrials.gov registry record
The Microenvironment in Barrett's Esophagus
A clinical trial, sponsored by Columbia University.
- Completed
- Registry status
- 155
- Enrollment target
NCT03060642: Completed study, sponsored by Columbia University.
NCT03060642 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 155 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03060642 has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 155 participants
- Enrollment target
Study Summary
This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers). The study will evaluate these novel tests in combination with clinical and anthropometric factors to describe an optimal strategy for BE screening and monitoring.
Primary Outcome
Oral and esophageal microbiome
Interventions
- DEVICE Tethered capsule sponge
- DEVICE Electronic nose device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2022-11-30 |
What the finished NCT03060642 record still lists
NCT03060642 is an observational study that tracks outcomes without assigning an intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Tethered capsule sponge is the first listed.
NCT03060642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03060642 about?
NCT03060642 is a clinical study titled "The Microenvironment in Barrett's Esophagus". This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest ...
What is the current status of trial NCT03060642?
This trial is currently completed. The enrollment target is 155 participants. The study started on 2018-02-01. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT03060642?
The interventions under investigation include: Tethered capsule sponge (DEVICE), Electronic nose device (DEVICE).
Who is sponsoring clinical trial NCT03060642?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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