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Helicobacter Pylori Genome Project (HpGP)

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ClinicalTrials.gov Identifier: NCT02788214
Recruitment Status : Terminated (research determined not to be human subject research)
First Posted : June 2, 2016
Last Update Posted : December 19, 2020
Sponsor:
Collaborators:
New England Biolabs, USA
National Institute of Infectious Diseases, Japan
National Institute of Genetics, Japan
Chiba University, Japan
National Institute for Basic Biology, Japan
Instituto Mexicano de Seguro Social, Mexico
Universidade de Lisboa, Portugal
Instituto de Biomedicina de Valencia, Spain
University of Bath, UK
Vanderbilt University Medical Center, USA
Karolinska Institutet
University of Tokyo, Japan
Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany
Universidad de Chile, Chile
HOSEI University, Japan
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:

Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems, including stomach cancer. Researchers want to look at samples of the bacteria. These H. pylori strains will be taken from chronically infected people. They want to identify the genetic and epigenetic differences in H. pylori strains. This could help predict which people who get infected with the bacteria will get stomach 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 30-70 years 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/DCEG. 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 : 1000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Helicobacter Pylori Genome Project (HpGP)
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

MedlinePlus related topics: Stomach Cancer

Group/Cohort
Advanced intestinal metaplasia

H. pylori strains from patients with:

  • Complete-type intestinal metaplasia with extension to corpus, or
  • Incomplete-type intestinal metaplasia of any extent
Non-atrophic gastritis
H. pylori strains from patients with non-atrophic gastritis
Gastric cancer
H. pylori strains from patients with gastric cancer



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


Biospecimen Retention:   Samples With DNA
Helicobacter pylori strains.


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
H. pylori strains from patients with various gastrointestinal diseases.
Criteria

INCLUSION CRITERIA:

H. pylori strains collected from:

  1. Adult aged 30 to 70 years old.
  2. Patients who need upper endoscopy (examination of the lining of their stomach with a flexible tube).
  3. Patients 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


Locations
Show Show 94 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
New England Biolabs, USA
National Institute of Infectious Diseases, Japan
National Institute of Genetics, Japan
Chiba University, Japan
National Institute for Basic Biology, Japan
Instituto Mexicano de Seguro Social, Mexico
Universidade de Lisboa, Portugal
Instituto de Biomedicina de Valencia, Spain
University of Bath, UK
Vanderbilt University Medical Center, USA
Karolinska Institutet
University of Tokyo, Japan
Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany
Universidad de Chile, Chile
HOSEI University, Japan
Investigators
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Principal Investigator: Charles S. Rabkin, M.D. National Cancer Institute (NCI)
Principal Investigator: M. Constanza Camargo, Ph.D. National Cancer Institute (NCI)
Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02788214    
Other Study ID Numbers: NCI-2020-07069
16-C-N120
999916120 ( Other Identifier: National Cancer Institute )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Keywords provided by National Cancer Institute (NCI):
Gastric Cancer
Bacterial Risk Factors
DNA Methylation
DNA Sequencing
Biobank
Helicobacter pylori
SMRT/PacBio
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastritis
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastroenteritis
Pathologic Processes