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NCT02521285 · ClinicalTrials.gov registry record · Phase 2
Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation
A Phase 2 study of Esophageal Adenocarcinoma and Barrett Esophagus, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 10
- Study locations
NCT02521285: Active Phase 2 study of Esophageal Adenocarcinoma and Barrett Esophagus, sponsored by National Cancer Institute (NCI).
NCT02521285 is a Phase 2 study of Esophageal Adenocarcinoma and Barrett Esophagus that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 308-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02521285, a Phase 2 study of Esophageal Adenocarcinoma and Barrett Esophagus, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 10
- Study locations
Study Summary
This randomized phase II trial studies the safety of and how well aspirin works in preventing Barrett's esophagus from returning after it has been successfully eliminated by radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus for the levels of a specific protein that is linked to developing Barrett's esophagus may help doctors learn whether aspirin can prevent it from returning after it has been successfully treated.
Primary Outcome
Measured the absolute and relative values in percentage of biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction.) The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Aspirin
- OTHER Placebo Administration
Study Locations (10)
Texas
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center - Houston
- M D Anderson Cancer Center - Houston
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Colorado
- UCHealth University of Colorado Hospital - Aurora
Illinois
- Northwestern University - Chicago
Minnesota
- Mayo Clinic in Rochester - Rochester
Missouri
- Kansas City Veterans Affairs Medical Center - Kansas City
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Pennsylvania
- University of Pennsylvania/Abramson Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-01-15 |
| Est. Completion | 2026-03-17 |
| Phase | Phase 2 |
What the registry record for NCT02521285 still lists
NCT02521285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 308-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02521285 lists 10 locations in 9 states (Texas, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT02521285 about?
NCT02521285 is a clinical study titled "Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation". This randomized phase II trial studies the safety of and how well aspirin works in preventing Barrett's esophagus from returning after it has been successfully eliminated by radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus for the levels of a specific protei...
What is the current status of trial NCT02521285?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2016-01-15. Estimated completion is 2026-03-17.
What conditions does trial NCT02521285 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Barrett Esophagus.
What interventions are being tested in trial NCT02521285?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Aspirin (DRUG), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT02521285?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02521285 being conducted?
This trial has 10 study locations across California, Colorado, Illinois, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02521285's enrollment target sits among peer trials
21 37th of 43 higher than 7 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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