Changes Associated With H. Pylori and Gastric Carcinogenesis (IIT H pylori)

Next-Generation Sequencing to Evaluate Transcriptomic Changes Associated With H. Pylori Infection and Gastric Cancer Carcinogenesis

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 Overview

• Status: Recruiting
• Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
• Intervention / Treatment: Procedure: Endoscopy tissue collection

Detailed 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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: June Greenberg, BSN,RN; Phone Number: 212-746-2651; Email: jdg2002@med.cornell.edu
• Study Contact Backup: Name: Casey Owens, MPH; Phone Number: 646-962-3541; Email: cdo4001@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medical College
      • Contact: June Greenberg, RN; Email: jdg2002@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects for this study will be either H. pylori positive with an active infection, cleared of an H. pylori infection or be both H. pylori antibody positive and have a malignancy of the gastrointestinal tract, specifically gastric adenocarcinoma. Of note, a small subset of patients without H. pylori infection will be enrolled as well (n=30) to serve as a control group.

Description

Inclusion Criteria:

• Patient must be 18 years or older
• Patient must have active or prior H. pylori infection, or have been treated for H.pylori infection in the past, as assessed by ELISA (not applicable for the subset of patient controls) or have gastric or esophageal cancer or have Barrett's Esophagus
• Patients must be eligible for and are planning to undergo a routine upper endoscopy and tissue biopsy
• Patients must sign informed consent

Exclusion Criteria:

• Prior history of upper GI bleed (within 3 months)
• Bleeding disorder or coagulopathy
• Recent stroke or myocardial infarction (within 3 months)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Subjects for this study will be either H. pylori positive with an active infection, cleared of an H. pylori infection or be both H. pylori antibody positive and have a malignancy of the gastrointestinal tract, specifically gastric adenocarcinoma.	Procedure: Endoscopy tissue collection; The investigational part of this study is the requirement for an additional biopsy from a site that is already being biopsied at the time of a routine endoscopy. Any patients who develop bleeding following their routine clinical biopsies will not undergo any additional research biopsies.
Control; A small subset of patients without H. pylori infection will be enrolled as well (n=30) to serve as a control group.	Procedure: Endoscopy tissue collection; The investigational part of this study is the requirement for an additional biopsy from a site that is already being biopsied at the time of a routine endoscopy. Any patients who develop bleeding following their routine clinical biopsies will not undergo any additional research biopsies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify genomic alterations associated with H. pylori infection	Ability to obtain adequate tissue for next generation sequencing from endoscopy	Within 3 years of tissue collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine bacterial content in samples	High-throughput DNA and RNA sequencing will be used to determine bacterial content of samples	at time of sample collection

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Manish Shah, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimated): June 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Bacterial Infections and Mycoses; Infections; Bacterial Infections; Carcinogenesis
• Other Study ID Numbers: 1203012274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No