Changes Associated With H. Pylori and Gastric Carcinogenesis

NCT02164409 | Recruiting

• 1 other identifier: 1203012274
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Examine bacterial content in samples

  at time of sample collection

Study Arms (2)

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

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

Interventions

Endoscopy tissue collection PROCEDURE

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; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

To examine RNA tranome of gastric cancer mucosa, in patients with H. pylori infection \& examine spectrum of disease associated with infection. We will also examine bacterial content of samples to pinpoint specific H. pylori strain(s) \& stomach microbial profile to correlate with gastric mucosal tranome \& predisposition of gastric cancer. We plan to take 2-3 additional biopsies from an area of stomach already being sampled. The biopsies will be used for next-generation RNA \& DNA sequencing \& novel bioinformatics analyses. Examination of the genetic impact of H. pylori infection in patients may expose genetic factors that influence gastric cancer carcinogenesis \& give deeper insight into molecular pathways that serve as candidate biomarkers for gastric cancer carcinogenesis.

Study Officials

• Manish Shah, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey Owens, MPH

CONTACT

646-962-3541; cdo4001@med.cornell.edu

June Greenberg, BSN,RN

CONTACT

212-746-2651; jdg2002@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 16, 2014
• Study Start: July 1, 2012
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)