Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation
BetrnetRF
Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus
2 other identifiers
observational
125
1 country
2
Brief Summary
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 29, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2018
CompletedDecember 15, 2021
December 1, 2021
6.6 years
March 29, 2012
December 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to therapy
evaulation will be made at 3 month intervals for one year post ablation
one year post ablation
Study Arms (1)
Radiofrequency ablation
participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)
Interventions
evaluate specific markers for response to therapy at specific intervals pre and post therapy
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Columbia University
New York, New York, 10032, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104-4311, United States
Related Links
Biospecimen
biopsy samples, serum, plasma, buffycoat, cytology brushings
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth K Wang, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 29, 2012
First Posted
April 2, 2012
Study Start
January 1, 2012
Primary Completion
August 16, 2018
Study Completion
August 16, 2018
Last Updated
December 15, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share