Barrett's Esophagus Clinical Trial
— FBEOfficial title:
Genetic and Environmental Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
The overall objectives of this BETRNet Research Center (RC) are: 1. to conduct a rigorous, integrated spectrum of transdisciplinary human research in Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA) 2. to increase the biological understanding of key observations made by our clinical researchers; 3. to translate knowledge derived from genetic, epigenetic, and transcriptome research to solving clinical dilemmas in detection, prognosis, prevention, and therapy of BE in order to prevent EAC and improve the outcomes of EAC; 4. to foster a transdisciplinary and translation research culture and to effectively expand and enhance scientific research focused on BE and EAC; 5. to evaluate research and transdisciplinary programs and to continuously improve research, productivity and enhance translational implementation. These objectives build and synergize on existing multi-institutional collaborative networks and the considerable clinical, basic science, and translational expertise available at our institutions, focusing on improving the outcomes of patients with BE and EAC. The overarching organization framework for this RC proposal is 1) to focus laboratory research on understanding the genetic susceptibility, genomic and epigenetic changes that influence the development of BE and EAC; and 2) to then translate laboratorydiscoveries into clinical applications for effective detection, molecular risk stratification, and prevention of progression from BE to EAC.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | July 31, 2028 |
Est. primary completion date | July 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Eligible cases will be defined as those patients and their family members who meet the following criteria: - Barrett's esophagus confirmed by review of pathology and endoscopy report or adenocarcinoma of the esophagus or family members of person with Barrett's esophagus or adenocarcinoma of the esophagus. - Male or female age 18 or older at time of enrollment or male or female less than 18 years of age at time of enrollment with parental consent. - Ability to give informed consent, if patient is age 18 or older. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Columbia University Medical Center | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Fred Hutchinson Cancer Research Center, UWMC | Seattle | Washington |
United States | VA Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University | Columbia University, Fred Hutchinson Cancer Center, Johns Hopkins University, Mayo Clinic, Mercy Medical Center, The Cleveland Clinic, University Hospitals Cleveland Medical Center, University of North Carolina, Chapel Hill, University of Pennsylvania, University of Washington, VA Puget Sound Health Care System, Washington University School of Medicine |
United States,
Douville C, Moinova HR, Thota PN, Shaheen NJ, Iyer PG, Canto MI, Wang JS, Dumot JA, Faulx A, Kinzler KW, Papadopoulos N, Vogelstein B, Markowitz SD, Bettegowda C, Willis JE, Chak A. Massively Parallel Sequencing of Esophageal Brushings Enables an Aneuploidy-Based Classification of Patients With Barrett's Esophagus. Gastroenterology. 2021 May;160(6):2043-2054.e2. doi: 10.1053/j.gastro.2021.01.209. Epub 2021 Jan 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assay of DNA and RNA markers | The Balloon tip is collected and sent to the PacificDx Laboratory in Irvine California to test for DNA extraction | 1 week | |
Secondary | Score of tolerability and acceptability | 6 item scale rating scale using scale of 1-10 where 1 is no worries to 10 being severe to rate Tolerability; and a 3 item scale rating the acceptability of Balloon Capsule Device using strongly agree to strongly disagree rating | 1 minute after procedure |
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