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

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ClinicalTrials.gov Identifier: NCT02164409
Recruitment Status : Recruiting
First Posted : June 16, 2014
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date June 10, 2014
First Posted Date June 16, 2014
Last Update Posted Date June 29, 2021
Actual Study Start Date July 2012
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 12, 2014)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes Associated With H. Pylori and Gastric Carcinogenesis
Official Title Next-Generation Sequencing to Evaluate Transcriptomic Changes Associated With H. Pylori Infection and Gastric Cancer Carcinogenesis
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Procedure: Endoscopy tissue collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 30, 2017)
120
Original Estimated Enrollment
 (submitted: June 12, 2014)
50
Estimated Study Completion Date April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Julianna Brouwer, MPH 212-746-8539 jub2024@med.cornell.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02164409
Other Study ID Numbers 1203012274
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor Weill Medical College of Cornell University
Collaborators Not Provided
Investigators
Principal Investigator: Manish Shah, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date June 2021