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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01568723
Recruitment Status : Active, not recruiting
First Posted : April 2, 2012
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Barrett's Esophagus Genetic: response to 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.

Study Design

Study Type : Observational
Actual Enrollment : 125 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Response to therapy [ Time Frame: one year post ablation ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568723


Locations
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104-4311
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
More Information

Responsible Party: Kenneth K. Wang, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01568723     History of Changes
Other Study ID Numbers: 11-006510
U54CA163004 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kenneth K. Wang, 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