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NCT01568723 Clinical Trial

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

Barrett's Esophagus Clinical Trial

— BetrnetRF  

Official title:
Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01568723
Other study ID # 11-006510
Secondary ID U54CA163004
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date August 16, 2018

Study information
Verified date December 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date August 16, 2018
Est. primary completion date August 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• response to therapy
evaluate specific markers for response to therapy at specific intervals pre and post therapy

Locations
Country Name City State
United States Columbia University New York New York
United States University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response to therapy evaulation will be made at 3 month intervals for one year post ablation one year post ablation
See also
  Status Clinical Trial Phase
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Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT01976351 - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus N/A
Terminated NCT00526786 - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus Phase 4
Completed NCT01401699 - Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction N/A
Completed NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy N/A
Suspended NCT01580631 - Narrow Band Imaging Project on Barrett's Esophagus
Completed NCT01439633 - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus N/A
Completed NCT02879721 - Expression and Function of the Renin-Angiotensin System in the Esophagus Phase 0
Completed NCT01281618 - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus N/A
Completed NCT01439594 - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation N/A
Completed NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus N/A
Completed NCT00588575 - Ramanspectroscopy in Barrett's Esophagus
Recruiting NCT00288119 - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed NCT03813381 - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO). N/A
Completed NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition N/A
Not yet recruiting NCT02033070 - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System N/A
Completed NCT01961778 - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma N/A

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