Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation (BetrnetRF)

Mayo Clinic

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Genetic: response to therapy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01568723

U54CA163004 (U.S. NIH Grant/Contract)

11-006510

Details and patient eligibility

About

The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

Full description

This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
• BE length ≥ 2 cm and ≤ 8 cm.
• Able to return every 3 months for one year after ablation

Exclusion criteria

• Patients who are unable to be compliant with follow-up endoscopies
• patients who cannot tolerate Proton Pump inhibitors
• pre-existing esophageal strictures
• pregnant or nursing women

Trial design

125 participants in 1 patient group

Radiofrequency ablation

Description:

participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)

Treatment:

Genetic: response to therapy