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Helicobacter Pylori Genome Project (HpGP)

Helicobacter Pylori Genome Project (HpGP)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02788214
Enrollment
1000
Registered
2016-06-02
Start date
2016-07-27
Completion date
2020-05-15
Last updated
2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Intestinal Metaplasia, Non-Atrophic Gastritis

Keywords

Gastric Cancer, Bacterial Risk Factors, DNA Methylation, DNA Sequencing, Biobank, Helicobacter pylori, SMRT/PacBio

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.

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.

Interventions

None listed

Sponsors

New England Biolabs, USA
CollaboratorUNKNOWN
National Institute of Infectious Diseases, Japan
CollaboratorUNKNOWN
National Institute of Genetics, Japan
CollaboratorUNKNOWN
Chiba University, Japan
CollaboratorUNKNOWN
National Institute for Basic Biology, Japan
CollaboratorUNKNOWN
Instituto Mexicano del Seguro Social
CollaboratorOTHER_GOV
Universidade de Lisboa, Portugal
CollaboratorUNKNOWN
Instituto de Biomedicina de Valencia, Spain
CollaboratorUNKNOWN
University of Bath, UK
CollaboratorUNKNOWN
Vanderbilt University Medical Center, USA
CollaboratorUNKNOWN
Karolinska Institutet
CollaboratorOTHER
University of Tokyo, Japan
CollaboratorUNKNOWN
Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany
CollaboratorUNKNOWN
Universidad de Chile, Chile
CollaboratorUNKNOWN
HOSEI University, Japan
CollaboratorUNKNOWN
National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bacterial DNA sequenceAt enrollmentgenome and methylome

Countries

Algeria, Argentina, Bangladesh, Belgium, Brazil, Bulgaria, Burma, Cameroon, Canada, Chile, Colombia, Costa Rica, Democratic Republic of the Congo, Dominican Republic, France, Germany, Ghana, Greece, Guatemala, Honduras, Iceland, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lithuania, Malaysia, Mexico, Nepal, Nigeria, Peru, Poland, Portugal, Puerto Rico, Russia, Singapore, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United States, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026