Stratifying Risk in Barrett*s Esophagus: A Pilot Study for Biomarker-Based Patient Management

Completed

• Conditions: Barrett's esophagus; esophageal cancer; 10017990

• Registration Number: NL-OMON41809
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

1) Pregnant women.
2) 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).
3) Known bleeding disorder.
4) Status post partial or complete esophageal resection.
5) 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).
6) 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The endpoints for the study consist of:<br /><br>1) Time taken to produce biomarker results,<br /><br>2) Consistency of biomarker prevalence between the centers (Europe and the<br /><br>U.S.), and,<br /><br>3) Proportion of patients falling into the high risk category based on<br /><br>biomarker analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>