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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02164409
Recruitment Status : Recruiting
First Posted : June 16, 2014
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
DeGregorio Family Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment
Bacterial Infection Due to Helicobacter Pylori (H. Pylori) 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Next-Generation Sequencing to Evaluate Transcriptomic Changes Associated With H. Pylori Infection and Gastric Cancer Carcinogenesis
Actual Study Start Date : July 2012
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.




Primary Outcome Measures :
  1. Differences in tranional profiles of samples [ Time Frame: at time of sample collection ]
    Identify differences in tranional profiles and dysregulated pathways between patient groups with variable response to H. pylori infection


Secondary Outcome Measures :
  1. Examine bacterial content in samples [ Time Frame: at time of sample collection ]
    High-throughput DNA and RNA sequencing will be used to determine bacterial content of samples


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164409


Contacts
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Contact: Julianna Brouwer, MPH 212-746-8539 jub2024@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Alice Mercado, RN    646-962-3080    alm2051@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
DeGregorio Family Foundation
Investigators
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Principal Investigator: Manish Shah, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02164409    
Other Study ID Numbers: 1203012274
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Bacterial Infections
Carcinogenesis
Neoplastic Processes
Neoplasms
Pathologic Processes