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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00288119.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Amitabh Chak
Phone: 216-844-5386
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 It is withdrawn until a tug is felt to locate the gastroesophageal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protective capsule, and then withdrawn.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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationCase Western Reserve University
