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Helicobacter Pylori Genome Project

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. Read our disclaimer for details. Identifier: NCT02788214
Recruitment Status : Terminated (research determined not to be human subject research)
First Posted : June 2, 2016
Last Update Posted : May 20, 2020
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.


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.


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


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
Actual Enrollment : 821 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Helicobacter Pylori Genome Project
Actual Study Start Date : July 27, 2016
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

    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 identifier (NCT number): NCT02788214

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Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Charles S Rabkin, M.D. National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT02788214    
Other Study ID Numbers: 999916120
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gastric Cancer
Bacterial Risk Factors
DNA Methylation
DNA Sequencing
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes