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

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ClinicalTrials.gov Identifier: NCT01568723
Recruitment Status : Active, not recruiting
First Posted : April 2, 2012
Last Update Posted : August 3, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic

March 29, 2012
April 2, 2012
August 3, 2017
January 2012
August 2018   (Final data collection date for primary outcome measure)
Response to therapy [ Time Frame: one year post ablation ]
evaulation will be made at 3 month intervals for one year post ablation
Same as current
Complete list of historical versions of study NCT01568723 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation
Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.
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.
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
biopsy samples, serum, plasma, buffycoat, cytology brushings
Non-Probability Sample
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.
Barrett's Esophagus
Genetic: response to therapy
evaluate specific markers for response to therapy at specific intervals pre and post therapy
Radiofrequency ablation
participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)
Intervention: Genetic: response to therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
August 2020
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
U54CA163004 ( U.S. NIH Grant/Contract )
Not Provided
Plan to Share IPD: No
Kenneth K. Wang, Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
Mayo Clinic
August 2017