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Stratifying Risk in Barrett's Esophagus: A Pilot Study for Biomarker-based Patient Management

NCT02075905 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2016-12-20

No results posted yet for this 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

  • Barrett's Esophagus
  • Esophageal Adenocarcinoma
  • Intestinal Metaplasia
  • Dysplasia

Sponsors & Collaborators

  • American Society for Gastrointestinal Endoscopy

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Nicholas J Shaheen, MD, MPH · UNC-Chapel Hill

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075905 on ClinicalTrials.gov