Esophageal Cancer Clinical Trial

Genetic Determinants of Barrett’s Esophagus and Esophageal Adenocarcinoma

Summary

The overall objectives of this BETRNet Research Center (RC) are:

to conduct a rigorous, integrated spectrum of transdisciplinary human research in Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA)
to increase the biological understanding of key observations made by our clinical researchers;
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;
to foster a transdisciplinary and translation research culture and to effectively expand and enhance scientific research focused on BE and EAC;
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.

View Full Description

Full Description

This research will eventually lead to the identification of inherited genetic changes that cause Barrett's esophagus and esophageal cancer. It will help the investigators develop better methods for preventing or identifying esophageal cancer at an early curable stage.

The capsule can be swallowed with a few sips water. Once the capsule is advanced to 45-50 cm from the incisors and reaches the stomach the balloon is inflated to a size of 16 mm with 5.5 cc air. It is withdrawn until a tug is felt to locate the gastroesophageal junction (GEJ). The inflated balloon is then pulled back 3 to 5 cm to sample the distal esophagus, then completely deflated to cause inversion of the biospecimen into its protective capsule, and then withdrawn. The balloon is re-inflated outside the patient and the obtained sample is clipped with scissors into a vial and frozen. The collected biospecimen will be stored frozen for later DNA extraction and assay. The vials will be labeled with a coded sample number. In a pilot study of 120 subjects this capsule esophageal sampling was performed with no adverse events reported. Similar esophageal sampling devices have been reported on over 1600 patients with no adverse events.

All patients will also undergo standard EGD. Patients with BE or EAC will have standard of care surveillance and diagnostic biopsies. All cases and controls will have research esophageal brushings from the BE/EAC and distal esophagus/gastric cardia, respectively. Cases and controls will also obtain research brushings from the proximal normal squamous esophagus. Research mucosal biopsies will also be obtained from the BE and EAC epithelium as well as normal stomach and duodenum in cases and from the gastric cardia and the distal squamous esophagus as well as normal stomach and duodenum in controls. Biopsies from BE and EAC will be directed by using high definition narrow band imaging. Biospecimens, brushings and biopsies, will be snap frozen at bedside and stored for future research assays. Although we do not anticipate any problems with our non-endoscopic balloon screening, these archived pathology samples and snap frozen samples will be available for assay in case we fail to detect our markers in patients with BE diagnosed at EGD or experience a high false positive rate. Subjects who undergo non-endoscopic sampling of the distal esophagus will be asked questions that rate their discomfort on a Likert scale and also asked questions comparing the non-endoscopic sampling study with an EGD.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

2000

Study ID:

NCT00288119

Recruitment Status:

Recruiting

Sponsor:

University Hospitals Cleveland Medical Center

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There are 10 Locations for this study

See Locations Near You

Johns Hopkins Hospital
Baltimore Maryland, 21205, United States More Info
Marcia Canto, M.D.
Contact
410-614-5388
Hilary Cosby, RN
Contact
(410) 502-2893
[email protected]
Marcia I Canto, M.D.
Principal Investigator
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Ganapathy A Prasad, M.D.
Contact
507-255-6930
[email protected]
Ramona Lansing
Contact
507-538-4974
[email protected]
Ganapathy A Prasad, M.D.
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Jean Wang, MD
Contact
314-362-5952
[email protected]
Thomas Hollander
Contact
314-747-1973
[email protected]
Jean Wang, MD
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States More Info
Julian Abrams, MD
Contact
212-342-0476
[email protected]
Adriana Rodriquez
Contact
212-304-5606
Julian Abrams, MD
Principal Investigator
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States More Info
Nicholas J Shaheen, M.D.
Contact
919-966-2513
[email protected]
Alondra Santiago
Contact
(919) 843-8571
[email protected]
Nicholas J Shaheen, M.D.
Principal Investigator
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States More Info
Amitabh Chak, MD
Contact
216-844-5386
[email protected]
Wendy Brock, RN
Contact
216-844-3853
[email protected]
Amitabh Chak, MD
Principal Investigator
John Dumot, MD
Sub-Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Prashanthi Thota, MD
Contact
216-444-0780
[email protected]
Vidhi Patel, MD
Contact
(216) 444-0780
[email protected]
Prashanthi Thota, MD
Principal Investigator
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Gary W Falk, MD, MS
Contact
215-615-6588
[email protected]
Maureen Demarshall, RN
Contact
215-349-8546
[email protected]
Gary W. Falk, MD, MS
Principal Investigator
VA Puget Sound Health Care System
Seattle Washington, 98108, United States More Info
Andrew Kaz, MD
Contact
Julie LaGuire
Contact
206-277-6662
[email protected]
Fred Hutchinson Cancer Research Center, UWMC
Seattle Washington, 98109, United States More Info
William Grady, MD
Contact
206-667-1107
[email protected]
Wynn Burke
Contact
[email protected]
William Grady, MD
Principal Investigator
Kaz Andrew, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

2000

Study ID:

NCT00288119

Recruitment Status:

Recruiting

Sponsor:


University Hospitals Cleveland Medical Center

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