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

This study is currently recruiting participants.
Verified November 2012 by Mayo Clinic
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01568723
First received: March 29, 2012
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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

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 2018
Estimated Primary Completion Date: August 2017 (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 3 month intervals

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.

  Eligibility

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568723

Contacts
Contact: Kenneth K Wang, MD 507-284-2174 wang.kenneth@mayo.edu
Contact: Lori S Lutzke 507-255-7612 lutzke.lori@mayo.edu

Locations
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Julian Abrams, MD     212-304-5606     ja660@mail.cumc.columbia.edu    
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     Gary.Falk@uphs.upenn.edu    
Sub-Investigator: Gary W Falk, MD MS            
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Kenneth K. Wang, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01568723     History of Changes
Other Study ID Numbers: 11-006510, U54CA163004
Study First Received: March 29, 2012
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013