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NCT05753748 · ClinicalTrials.gov registry record · NA
Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia
A NA study of Esophageal Adenocarcinoma and Barrett Esophagus, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 680
- Enrollment target
- 20
- Study locations
NCT05753748: Recruiting NA study of Esophageal Adenocarcinoma and Barrett Esophagus, sponsored by University of Colorado, Denver.
NCT05753748 is a NA study of Esophageal Adenocarcinoma and Barrett Esophagus that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 680 participants, above the 293-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (132% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05753748, a NA study of Esophageal Adenocarcinoma and Barrett Esophagus, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 680 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy. To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments. While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other. Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia. This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 pa
Primary Outcome
The occurrence of high grade dysplasia/mucosal post-endoscopy esophageal adenocarcinoma/invasive post-endoscopy esophageal adenocarcinoma at any time during the study period following enrollment.
Conditions Studied
Interventions
- PROCEDURE Endoscopic Eradication Therapy
Study Locations (20)
California
- University of California, Los Angeles - Los Angeles
- Kaiser Permanente Oakland Medical Center - Oakland
- Kaiser Permanente - San Jose
New York
- Long Island Jewish Medical Center - Manhasset
- Columbia Universtiy - New York
- University of Rochester Medical Center - Rochester
Ohio
- University Hospitals Cleveland Medical Center Case Western University - Cleveland
- Cleveland Clinic Foundation - Cleveland
Pennsylvania
- University of Pennsylania, Perelman School of Medicine - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Colorado
- University of Colorado - Aurora
Florida
- Florida Digestive Health Specialists - Sarasota
Illinois
- Northwestern Memorial Hospital - Chicago
Indiana
- Indiana University Melvin & Bren Simon Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2023-01-24 |
| Est. Completion | 2029-04-30 |
| Phase | NA |
What NCT05753748 shows while recruiting
NCT05753748 is an interventional study that assigns participants to a tested intervention. The registered 680 participants enrollment target is mid-sized for trials with a published cap, above the 293-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (132% higher).
The record links to 3 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Endoscopic Eradication Therapy is the first listed.
NCT05753748 names 20 study sites across 14 states, led by California, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT05753748 about?
NCT05753748 is a clinical study titled "Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia". The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy. To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called...
What is the current status of trial NCT05753748?
This trial is currently recruiting. It is a NA study. The enrollment target is 680 participants. The study started on 2023-01-24. Estimated completion is 2029-04-30.
What conditions does trial NCT05753748 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Barrett Esophagus, Barretts Esophagus With Dysplasia.
What interventions are being tested in trial NCT05753748?
The interventions under investigation include: Endoscopic Eradication Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT05753748?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05753748 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Indiana. 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 NCT05753748's enrollment target sits among peer trials
680 7th of 43 higher than 37 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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