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

Completed

Conditions studied: Barrett's Esophagus, Esophageal Adenocarcinoma, Intestinal Metaplasia, Dysplasia

In brief

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.

Key facts

Study ID

NCT02075905

Run by

University of North Carolina, Chapel Hill

People needed

111

Starts

2014-03-01

Expected to finish

2015-08-01

Last updated by the study team

2016-12-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to read, comprehend, and complete the consent form.
• Aged 18 to 80.
• Diagnosed with at least 3 centimeters (>3cm) of Barrett's Esophagus (BE) AND no dysplasia or low grade dysplasia per review by pathologist.

You may not qualify if…

• Pregnant women.
• Current use of blood thinners such as coumadin, warfarin, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after EGD).
• Known bleeding disorder.
• Status post partial or complete esophageal resection.
• Current or past diagnosis of invasive esophageal cancer (previous intramucosal cancer is allowable, if removed by endoscopic mucosal resection with histologically confirmed negative lateral and deep margins).
• Prior ablative therapy of the esophagus including prior radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, and other ablation therapies. Prior endoscopic mucosal resection (EMR) is acceptable.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Academic Medical Center — Amsterdam, Netherlands
• University of Cambridge — Cambridge, United Kingdom

Full record on ClinicalTrials.gov

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