This is a research study for patients who currently have or previously had an H. pylori
infection or who have gastric or esophageal cancer and who plan to undergo an endoscopy
as part of their care. The purpose of this study is to find out how and why H. pylori
infections can cause progression to gastric cancer and if it's possible for intervention
prior to this progression.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02164409.
H. pylori infection is a prevalent environmental cause of gastric cancer. The molecular
mechanisms of carcinogenesis due to H. pylori remain unexplained and consequences of
infection are variable and unpredictable. The aim of this research is to examine the RNA
transcriptome of gastric cancer mucosa (gastric mucosa is the mucus membrane of the
stomach), in patients with H. pylori infection and examine the spectrum of disease
associated with infection. We will also examine bacterial content of samples to pinpoint
the specific H. pylori strain(s) and the stomach microbial profile to correlate with the
gastric mucosal transcriptome and predisposition of gastric cancer. Patients with prior
or current active H. pylori infection who are planning to under endoscopic evaluation
will be eligible for participation. From these patients, we plan to take up to four
additional biopsies from each area of stomach already being sampled.
The biopsies will be used for next-generation RNA and DNA sequencing and novel
bioinformatics analyses. The analysis will be performed at Weill Cornell Medical College
by Doron Betel, PhD. The sequencing will be performed in the Epigenetics Core laboratory
under the supervision of Doron Betel, who will be working closely with the principal
investigator, Manish A. Shah, M.D. Examination of the genetic impact of H. pylori
infection in patients may expose genetic factors that influence gastric cancer
carcinogenesis and give deeper insight into molecular pathways that serve as candidate
biomarkers for gastric cancer carcinogenesis. Our goal is to distinguish patients with
chronic H. pylori infection who are at risk of subsequently developing gastric cancer
from the vast majority of patients with H. pylori infection who do not develop
malignancy.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNYP/Weill Cornell Medical Center