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NCT04939051 · ClinicalTrials.gov registry record · Phase 2

Obeticholic Acid for Prevention in Barrett's Esophagus

A Phase 2 study of Esophageal Adenocarcinoma and Barrett Esophagus, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
30
Enrollment target
8
Study locations

NCT04939051: Recruiting Phase 2 study of Esophageal Adenocarcinoma and Barrett Esophagus, sponsored by National Cancer Institute (NCI).

NCT04939051 is a Phase 2 study of Esophageal Adenocarcinoma and Barrett Esophagus that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 308-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (90% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04939051, a Phase 2 study of Esophageal Adenocarcinoma and Barrett Esophagus, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
8
Study locations

Study Summary

This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression.

Primary Outcome

The mean difference in this percentage is compared across the two study arms by means of a two-sample t-test. As a further sensitivity analysis, the outcome of change will be analyzed under a linear regression model framework, controlling for factors such as age, sex, body mass index, and grade of dysplasia.

Conditions Studied

Esophageal Adenocarcinoma Barrett Esophagus

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Esophagogastroduodenoscopy
  • PROCEDURE Esophageal Biopsy
  • PROCEDURE Liver Ultrasonographic Elastography
  • BIOLOGICAL Obeticholic Acid

Study Locations (8)

Ohio

  • Case Western Reserve University - Cleveland
  • Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center - Cleveland
  • University Hospitals Cleveland Medical Center - Cleveland
  • Cleveland Clinic Foundation - Cleveland

Kansas

  • University of Kansas Cancer Center - Kansas City

Michigan

  • University of Michigan Rogel Cancer Center - Ann Arbor

Missouri

  • Washington University School of Medicine - St Louis

North Carolina

  • UNC Lineberger Comprehensive Cancer Center - Chapel Hill

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-01-03
Est. Completion 2027-09-01
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT04939051 shows while recruiting

NCT04939051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 308-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (90% lower).

The record links to 2 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04939051 lists 8 locations in 5 states (Ohio, Kansas, Michigan).

Frequently Asked Questions

What is clinical trial NCT04939051 about?

NCT04939051 is a clinical study titled "Obeticholic Acid for Prevention in Barrett's Esophagus". This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic...

What is the current status of trial NCT04939051?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-01-03. Estimated completion is 2027-09-01.

What conditions does trial NCT04939051 study?

This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Barrett Esophagus.

What interventions are being tested in trial NCT04939051?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Esophagogastroduodenoscopy (PROCEDURE), Esophageal Biopsy (PROCEDURE), Liver Ultrasonographic Elastography (PROCEDURE), Obeticholic Acid (BIOLOGICAL).

Who is sponsoring clinical trial NCT04939051?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04939051 being conducted?

This trial has 8 study locations across Kansas, Michigan, Missouri, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Esophageal Adenocarcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04939051's enrollment target sits among peer trials

30 34th of 43 higher than 10 of 43 other Esophageal Adenocarcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Esophageal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04939051

Source: ClinicalTrials.gov NCT04939051, the US trial registry maintained by the National Library of Medicine. NCT04939051 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.