Helicobacter Pylori Genome Project (HpGP)

NCT02788214 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2020-12-19

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • New England Biolabs, USA

    collaborator UNKNOWN
  • National Institute of Infectious Diseases, Japan

    collaborator UNKNOWN
  • National Institute of Genetics, Japan

    collaborator UNKNOWN
  • Chiba University, Japan

    collaborator UNKNOWN
  • National Institute for Basic Biology, Japan

    collaborator UNKNOWN
  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV
  • Universidade de Lisboa, Portugal

    collaborator UNKNOWN
  • Instituto de Biomedicina de Valencia, Spain

    collaborator UNKNOWN
  • University of Bath, UK

    collaborator UNKNOWN
  • Vanderbilt University Medical Center, USA

    collaborator UNKNOWN
  • Karolinska Institutet

    collaborator OTHER
  • University of Tokyo, Japan

    collaborator UNKNOWN
  • Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany

    collaborator UNKNOWN
  • Universidad de Chile, Chile

    collaborator UNKNOWN
  • HOSEI University, Japan

    collaborator UNKNOWN
  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Charles S. Rabkin, M.D. · National Cancer Institute (NCI)

  • M. Constanza Camargo, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-27
Primary Completion
2020-05-15
Completion
2020-05-15

Countries

  • United States
  • 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)
  • Vietnam

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788214 on ClinicalTrials.gov