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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-01-03 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04939051
The ClinicalTrials.gov registry entry for NCT04939051 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 308-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (90% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 5 distinct geographic areas - top geographies include 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.
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