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Stratifying Risk in Barrett's Esophagus: A Pilot Study for Biomarker-based Patient Management
NCT02075905 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02075905
The ClinicalTrials.gov registry entry for NCT02075905 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02075905 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Other, North Carolina, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02075905?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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