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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41809
Enrollment
40
Registered
2014-06-16
Start date
2014-08-25
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus esophageal cancer

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)