Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma



Status:Recruiting
Conditions:Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:7/4/2018
Start Date:October 1, 2005
End Date:April 2022
Contact:Amitabh Chak, MD
Email:axc22@po.cwru.edu
Phone:216-844-5385

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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.

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 It is withdrawn until a tug is felt to locate the gastroesophageal junction (GEJ).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.

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.
We found this trial at
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sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Prashanthi Thota, MD
Phone: 216-444-0780
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Nicholas J Shaheen, M.D.
Phone: 919-966-2513
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1660 South Columbian Way
Seattle, Washington 98108
(206) 762-1010
VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Marcia I Canto, M.D.
Phone: 410-614-5388
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Amitabh Chak, MD
Phone: 216-844-5386
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Julian Abrams, MD
Phone: 212-342-0476
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Gary W. Falk, MD, MS
Phone: 215-615-6588
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Rochester, Minnesota 55905
Principal Investigator: Ganapathy A Prasad, M.D.
Phone: 507-255-6930
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Jean Wang, MD
Phone: 314-362-5952
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Seattle, Washington 98109
Principal Investigator: William Grady, MD
Phone: 206-667-1107
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