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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. (see Contacts and Locations)
Verified July 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01568723
First received: March 29, 2012
Last updated: July 29, 2014
Last verified: July 2014

March 29, 2012
July 29, 2014
January 2012
August 2018   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01568723 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.
 
Recruiting
160
August 2019
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
Both
18 Years and older
No
Contact: Kenneth K Wang, MD 507-284-2174 wang.kenneth@mayo.edu
Contact: Lori S Lutzke 507-255-7612 lutzke.lori@mayo.edu
United States
 
NCT01568723
11-006510, U54CA163004
No
Kenneth K. Wang, Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
Mayo Clinic
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP