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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 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 155 participants.

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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.

Interventions

  • DEVICE Tethered capsule sponge
  • DEVICE Electronic nose device

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2018-02-01
Est. Completion 2022-11-30

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT03060642

The ClinicalTrials.gov registry entry for NCT03060642 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Tethered capsule sponge is the first listed.

NCT03060642 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.