NCT00288119: FBE

Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

Recruiting now Last updated 18 July 2025

What this trial tests

trial testing Balloon Capsule Device in Barrett's Esophagus in 2,000 participants. Currently enrolling.

Timeline

1 October 2005

Primary endpoint
31 July 2028

31 July 2028

Quick facts

Lead sponsor	Case Western Reserve University
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	2,000
Start date	1 October 2005
Primary completion	31 July 2028
Estimated completion	31 July 2028
Sites	10 locations across United States

Drugs / interventions tested

• Balloon Capsule Device
• Endoscopy

Conditions studied

• Barrett's Esophagus — all drugs for Barrett's Esophagus →
• Esophageal Neoplasm — all drugs for Esophageal Neoplasm →

Sponsor

Case Western Reserve University

Who can join

18 and older, any sex, with Barrett's Esophagus or Esophageal Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Identifying DNA methylation biomarkers for non-endoscopic detection of Barrett's esophagus.
   Moinova HR, LaFramboise T, Lutterbaugh JD, Chandar AK, et al · · 2018 · cited 137× · PMID 29343623 · DOI 10.1126/scitranslmed.aao5848
2. A segregation analysis of Barrett's esophagus and associated adenocarcinomas.
   Sun X, Elston R, Barnholtz-Sloan J, Falk G, et al · · 2010 · cited 35× · PMID 20200424 · DOI 10.1158/1055-9965.epi-09-1136
3. Assessment of familiality, obesity, and other risk factors for early age of cancer diagnosis in adenocarcinomas of the esophagus and gastroesophageal junction.
   Chak A, Falk G, Grady WM, Kinnard M, et al · · 2009 · cited 35× · PMID 19491834 · DOI 10.1038/ajg.2009.241
4. Multicenter, Prospective Trial of Nonendoscopic Biomarker-Driven Detection of Barrett's Esophagus and Esophageal Adenocarcinoma.
   Moinova HR, Verma S, Dumot J, Faulx A, et al · · 2024 · cited 21× · PMID 38686933 · DOI 10.14309/ajg.0000000000002850
5. Variation in age at cancer diagnosis in familial versus nonfamilial Barrett's esophagus.
   Chak A, Chen Y, Vengoechea J, Canto MI, et al · · 2012 · cited 20× · PMID 22178570 · DOI 10.1158/1055-9965.epi-11-0927
6. Barrett's Esophagus and Esophageal Adenocarcinoma Biomarkers.
   Grady WM, Yu M, Markowitz SD, Chak A. · · 2020 · cited 18× · PMID 33093162 · DOI 10.1158/1055-9965.epi-20-0223
7. Novel DNA Methylation Biomarker Panel for Detection of Esophageal Adenocarcinoma and High-Grade Dysplasia.
   Yu M, Moinova HR, Willbanks A, Cannon VK, et al · · 2022 · cited 17× · PMID 35705525 · DOI 10.1158/1078-0432.ccr-22-0445
8. Age of diagnosis in familial Barrett's associated neoplasia.
   Glamour BK, Alaber O, Cioffi G, Chandar AK, et al · · 2022 · cited 4× · PMID 33694069 · DOI 10.1007/s10689-021-00239-z