Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02164409
Study type Observational
Source Weill Medical College of Cornell University
Contact Casey Owens, MPH
Phone 646-962-3541
Email cdo4001@med.cornell.edu
Status Recruiting
Phase
Start date July 2012
Completion date April 2025

See also
  Status Clinical Trial Phase
Recruiting NCT02553083 - High Dose Dual Therapy (HDDT) for Eradication of Helicobacter Pylori Infection Phase 4
Completed NCT01897909 - The Impact of Helicobacter Pylori Infection on Immune Regulation and Clinical Course in HIV Patients in Ghana
Completed NCT02160860 - Epidemiology of Helicobacter Pylori Infection Among Shanghai Children N/A
Completed NCT03367897 - Bleeding Ulcer and Erosions Study "BLUE Study"
Completed NCT01506986 - Helicobacter Eradication Aspirin Trial Phase 4
Recruiting NCT01572597 - Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy Phase 4
Completed NCT01623154 - POCone-UBiT-IR300 Pediatric Comparison Study Phase 4
Completed NCT01591486 - Helicobacter Pylori and the Long-term Risk of Peptic Ulcer Bleeding N/A
Completed NCT03124199 - Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection Phase 3
Recruiting NCT02674802 - Reinfection After Eradication of Helicobacter Pylori Infection N/A
Completed NCT02092506 - RCT: Triple vs Sequential vs Concomitant Therapy H Pylori Phase 4
Completed NCT01902589 - Resistance of Helicobacter Pylori to Antibiotics in Children N/A