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Helicobacter Pylori Genome Project

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ClinicalTrials.gov Identifier: NCT02788214
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems or stomach cancer. Researchers want to look at samples of the bacteria. These will be taken from chronically infected people. They want to identify the genetic differences in H. pylori strains. This could help predict which people who get infected with the bacteria will get cancer. This could lead to the cancer being detected earlier. It could also mean less people get stomach cancer.

Objectives:

To study genetic variations of H. pylori strains based on samples from chronically infected people. To identify the features of strains that might lead to severe stomach problems or stomach cancer.

Eligibility:

People ages 35 70 who need an upper endoscopy or who were recently diagnosed with stomach cancer

Design:

Participants will be screened by the doctor who does their procedure and a study nurse.

Participants who have endoscopy will have 6 biopsies removed. These are tissue samples. They are about the size of a grain of rice. Participants will allow the study team to access reports from their stomach exam.

Participants with stomach cancer will donate some of the tissue that will be removed during their clinical care. They will allow the study team to access reports of their surgery. They will also allow them to access the microscope slides of their stomach.


Condition or disease
Gastric Cancer Non-Atrophic Gastritis Intestinal Metaplasia

Detailed Description:
Helicobacter pylori, a Gram-negative bacterium associated with a spectrum of benign and malignant gastric conditions, is one of the most genetically variable pathogens. Variations in a few genes have been associated with risk of inflammation and carcinogenesis, but to date no systematic study has evaluated the entire bacterial genome. We propose a multicountry study to establish and analyze an informative international collection of H. pylori clinical isolates from residents of defined geographic areas. Molecular characterization will be conducted at the NCI/FNLCR. Our hypothesis is that genetic and epigenetic variations in H. pylori strains among chronically infected individuals may affect risk of progression to gastric cancer. Findings from this study may help to characterize the differential virulence among H. pylori isolates and suggest predictive biomarkers for early diagnosis of cancer. The bacterial isolates and databases from this study will also provide a foundation for further elucidation of H. pylori pathogenesis.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Helicobacter Pylori Genome Project
Actual Study Start Date : July 27, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Intestinal metaplasia
Patients with advanced intestinal metaplasia
Non-atrophic gastritis
Patients with non-atrophic gastritis



Primary Outcome Measures :
  1. Bacterial DNA sequence [ Time Frame: At enorllment ]
    genome and methylome



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
endoscopy patients
Criteria
  • INCLUSION CRITERIA:

    1. Adult aged 35 to 70 years old.
    2. Patients who need upper endoscopy (examination of the lining of their stomach with a flexible tube).
    3. Patients recently diagnosed with stomach cancer.

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): NCT02788214


Contacts
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Contact: Charles S Rabkin, M.D. (240) 276-7105 rabkinc@epndce.nci.nih.gov

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Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Charles S Rabkin, M.D. National Cancer Institute (NCI)

Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02788214     History of Changes
Other Study ID Numbers: 999916120
16-C-N120
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 17, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gastric Cancer
Bacterial Risk Factors
DNA Methylation
DNA Sequencing
Biobank

Additional relevant MeSH terms:
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Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Stomach Neoplasms
Gastritis
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Gastroenteritis
Pathologic Processes