Changes Associated With H. Pylori and Gastric Carcinogenesis

Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Clinical Trial

— IIT H pylori  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02164409
• Other study ID #: 1203012274
• Status: Recruiting
• Start date: July 2012
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Casey Owens, MPH
• Phone: 646-962-3541
• Email: cdo4001[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
• Bacterial Infections
• Carcinogenesis
• Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify genomic alterations associated with H. pylori infection	Ability to obtain adequate tissue for next generation sequencing from endoscopy	Within 2 years of tissue collection
Secondary	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