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NCT05524844 · ClinicalTrials.gov registry record
The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)
A clinical trial of Esophageal Adenocarcinoma and Barrett Esophagus, sponsored by Columbia University.
- Completed
- Registry status
- 54
- Enrollment target
- 2
- Study locations
NCT05524844: Completed study of Esophageal Adenocarcinoma and Barrett Esophagus, sponsored by Columbia University.
NCT05524844 is a study of Esophageal Adenocarcinoma and Barrett Esophagus that has completed, run by Columbia University. The registered enrollment target is 54 participants, below the 307-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05524844, a study of Esophageal Adenocarcinoma and Barrett Esophagus, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 54 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to prospectively collect and analyze clinical data and biospecimens from a cohort of 100 patients without BE (20), with non-dysplastic BE (40), or with BE and high grade dysplasia (HGD) or EAC (40). The investigators will enroll 80 patients scheduled for upper endoscopy for clinical purposes, with a history of histologically confirmed BE (2 cm length); 40 with no history of dysplasia, and 40 with HGD or EAC. The investigators will also enroll 20 non-BE controls undergoing endoscopy for any indication who are on stable dose proton-pump inhibitors (PPI) for the past month. PPI therapy is standard of care for BE patients.
Primary Outcome
To determine whether refluxate deoxycholic acid (DCA) is associated with increased Notch signaling in the development of esophageal adenocarcinoma (EAC), the investigators will calculate Pearson's correlation coefficients to assess within individual correlations between DCA and NOTCH3 gene expression.
Conditions Studied
Interventions
- OTHER Sample Collection
- OTHER Endoscopy results
- OTHER Dietary questionnaire
Study Locations (2)
New York
- Columbia University Irving Medical Center - New York
- Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2024-11-01 |
What the finished NCT05524844 record still lists
NCT05524844 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 307-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Sample Collection is the first listed.
NCT05524844 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05524844 about?
NCT05524844 is a clinical study titled "The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)". The purpose of this study is to prospectively collect and analyze clinical data and biospecimens from a cohort of 100 patients without BE (20), with non-dysplastic BE (40), or with BE and high grade dysplasia (HGD) or EAC (40). The investigators will enroll 80 patients scheduled for upper endoscopy ...
What is the current status of trial NCT05524844?
This trial is currently completed. The enrollment target is 54 participants. The study started on 2021-02-09. Estimated completion is 2024-11-01.
What conditions does trial NCT05524844 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Barrett Esophagus.
What interventions are being tested in trial NCT05524844?
The interventions under investigation include: Sample Collection (OTHER), Endoscopy results (OTHER), Dietary questionnaire (OTHER).
Who is sponsoring clinical trial NCT05524844?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05524844 being conducted?
This trial has 2 study locations across New York. 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 NCT05524844's enrollment target sits among peer trials
54 24th of 43 higher than 19 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.
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