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NCT02075905 · ClinicalTrials.gov registry record
Stratifying Risk in Barrett's Esophagus: A Pilot Study for Biomarker-based Patient Management
A clinical trial of Esophageal Adenocarcinoma and Barrett's Esophagus, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 111
- Enrollment target
- 4
- Study locations
NCT02075905: Completed study of Esophageal Adenocarcinoma and Barrett's Esophagus, sponsored by University of North Carolina, Chapel Hill.
NCT02075905 is a study of Esophageal Adenocarcinoma and Barrett's Esophagus that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 111 participants, below the 306-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (64% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02075905, a study of Esophageal Adenocarcinoma and Barrett's Esophagus, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 111 participants
- Enrollment target
- 4
- Study locations
Study Summary
Subjects enrolled in this study will have biopsies obtained and sent to Dr. Fitzgerald's lab for analysis of a validated biomarker panel. Subjects will be stratified to either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results. Biomarker panel results will not be communicated to sites. Subjects with low grade dysplasia will be offered the option of treatment (radiofrequency ablation (RFA)) as part of routine care. Subjects with low grade dysplasia who do not want RFA and subjects with no dysplasia will receive surveillance endoscopy in 1 year per routine care. All subjects will be administered a questionnaire seeking information about hypothetical willingness to be randomized to treatment or surveillance.
Primary Outcome
This is a pilot study the main objective of which is to determine feasibility and preparation for a larger scale study. Baseline tissue samples will be used to stratify subjects as either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results. Biomarker panel risk stratification will be compared to data collected 1 year post enrollment regarding current pathology and ablation treatments received since enrollment.
Conditions Studied
Study Locations (4)
Other
- Academic Medical Center - Amsterdam
- University of Cambridge - Cambridge
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Ohio
- Case Western Reserve University - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-08 |
What the finished NCT02075905 record still lists
NCT02075905 is an observational study that tracks outcomes without assigning an intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 306-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (64% lower).
The record links to 4 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 0 interventions.
NCT02075905 reports a single indexed study location in Other, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT02075905 about?
NCT02075905 is a clinical study titled "Stratifying Risk in Barrett's Esophagus: A Pilot Study for Biomarker-based Patient Management". Subjects enrolled in this study will have biopsies obtained and sent to Dr. Fitzgerald's lab for analysis of a validated biomarker panel. Subjects will be stratified to either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results. Biomarker panel results...
What is the current status of trial NCT02075905?
This trial is currently completed. The enrollment target is 111 participants. The study started on 2014-03. Estimated completion is 2015-08.
What conditions does trial NCT02075905 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Barrett's Esophagus, Dysplasia, Intestinal Metaplasia.
Who is sponsoring clinical trial NCT02075905?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02075905 being conducted?
This trial has 4 study locations across 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 NCT02075905's enrollment target sits among peer trials
111 17th of 43 higher than 27 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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