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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Mayo Clinic
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic Identifier:
First received: March 29, 2012
Last updated: January 4, 2016
Last verified: January 2016
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

Condition Intervention
Barrett's Esophagus
Genetic: response to therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Response to therapy [ Time Frame: one year post ablation ] [ Designated as safety issue: No ]
    evaulation will be made at 3 month intervals for one year post ablation

Biospecimen Retention:   Samples With DNA
biopsy samples, serum, plasma, buffycoat, cytology brushings

Estimated Enrollment: 160
Study Start Date: January 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Radiofrequency ablation
participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)
Genetic: response to therapy
evaluate specific markers for response to therapy at specific intervals pre and post therapy

Detailed 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants must have biopsy proven Barret's esophgus with evidence of specialized intestinal epithelium with high grade dysplasia or early intramucosal carcinoma (mEAC) on histology (confirmed by two pathologists). Patients must have a BE length ≥ 2 cm and ≤ 8 cm.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01568723

Contact: Kenneth K Wang, MD 507-284-2174
Contact: Lori S Lutzke 507-255-7612

United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Julian Abrams, MD    212-304-5606   
Sub-Investigator: Julian Abrams, MD         
United States, Pennsylvania
University of Pennsylvania Perelman School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104-4311
Contact: Gary W Falk, MD MS    215-615-4452   
Sub-Investigator: Gary W Falk, MD MS         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
  More Information

Responsible Party: Kenneth K. Wang, Principal Investigator, Mayo Clinic Identifier: NCT01568723     History of Changes
Other Study ID Numbers: 11-006510  U54CA163004 
Study First Received: March 29, 2012
Last Updated: January 4, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Mayo Clinic:
Barrett's esophagus
high grade dysplasia
radiofrequency ablation
esophageal cancer

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on May 30, 2016