Helicobacter Pylori Genome Project (HpGP)

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.

Study Overview

• Status: Terminated
• Conditions: Gastric Cancer; Intestinal Metaplasia; Non-Atrophic Gastritis

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Algeria
  • Sétif, Algeria
    • Université Ferhat Abbas
• Argentina
  • Buenos Aires, Argentina
    • Hospital Aleman
• Bangladesh
  • Dhaka, Bangladesh
    • Dhaka Medical College and Hospital
• Belgium
  • Ghent, Belgium
    • Ghent University
• Brazil
  • Belo Horizonte, Brazil
    • Universidade Federal De Minas Gerais
  • Sao Paulo, Brazil
    • AC Camargo Cancer Center
• Bulgaria
  • Sofia, Bulgaria
    • Medical University of Sofia
  • Sofia, Bulgaria
    • Tsaritsa Yoanna University Hospital
• Cameroon
  • Dschang, Cameroon
    • University of Dschang
• Canada
  • Edmonton, Canada
    • University of Alberta
• Chile
  • Concepción, Chile
    • Universidad de Concepcion
  • Easter Island, Chile
    • Hospital Hanga Roa
  • Santiago, Chile
    • Pontificia Universidad Católica
• Colombia
  • Bogotá, Colombia
    • Instituto Nacional De Cancerologia
  • Cali, Colombia
    • Universidad del Valle
  • Pasto, Colombia
    • Universidad de Nariño
• Congo, The Democratic Republic of the
  • Kinshasa, Congo, The Democratic Republic of the
    • University of Kinshasa
  • Mbuji-Mayi, Congo, The Democratic Republic of the
    • University of Mbuji Mayi
• Costa Rica
  • San José, Costa Rica
    • Universidad de Costa Rica
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Universidad Autónoma de Santo Domingo
• France
  • Bordeaux, France
    • C.H.U. Pellegrin
• Germany
  • Magdeburg, Germany
    • Otto-von-Guericke Universitätsklinikum
• Ghana
  • Cape Coast, Ghana
    • University of Cape Coast
• Greece
  • Athens, Greece
    • Evangelismos Hospital and Hellenic Pasteur Institute
  • Athens, Greece
    • Hellenic Pasteur Institute
• Guatemala
  • Guatemala, Guatemala
    • Universidad San Carlos
• Honduras
  • Santa Rosa De Copán, Honduras
    • Hospital de Occidente
• Iceland
  • Reykjavík, Iceland
    • National University Hospital
• India
  • Manipal, India
    • Kasturba Medical College Manipal
• Indonesia
  • Kota Depok, Indonesia
    • University of Indonesia
  • Kota Surabaya, Indonesia
    • Universitas Airlangga
• Iran, Islamic Republic of
  • Teheran, Iran, Islamic Republic of
    • Digestive Disease Research Institute
• Israel
  • Ramat Gan, Israel
    • Bar Ilan University
• Italy
  • Aviano, Italy
    • Centro di Rferimento Oncologico
• Japan
  • Nagoya, Japan
    • Nagoya City University
  • Tokyo, Japan
    • Nippon Medical School
  • Tokyo, Japan
    • Kyorin University
  • Tokyo, Japan
    • HOSEI University
  • Ōita, Japan
    • Oita University
• Jordan
  • Ramtha, Jordan
    • Jordan University of Science and Technology
• Kazakhstan
  • Almaty, Kazakhstan
    • Central Asian Cancer Institute
• Kenya
  • Bomet, Kenya
    • Tenwek Hospital
• Korea, Republic of
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • National Cancer Center
• Kyrgyzstan
  • Bishkek, Kyrgyzstan
    • Kyrgyz State Medical Academy
• Latvia
  • Riga, Latvia
    • University of Latvia
• Lithuania
  • Kaunas, Lithuania
    • Lithuanian University of Health Sciences
• Malaysia
  • Kuala Lumpur, Malaysia
    • University of Malaya
• Mexico
  • Mexico City, Mexico
    • Instituto Nacional De Cancerologia
• Myanmar
  • Yangon, Myanmar
    • Defence Services General Hospital
• Nepal
  • Bharatpur, Nepal
    • Chitwan Medical College
  • Kathmandu, Nepal
    • Tribhuvan University Teaching Hospital
• Nigeria
  • Calabar, Nigeria
    • University of Calabar Teaching Hospital
  • Enugu, Nigeria
    • University of Nigeria Teaching Hospital
  • Ilishan-Remo, Nigeria
    • Babcock Universtiy Teaching Hospital
  • Jos, Nigeria
    • University of Jos / University Teaching Hospital
  • Lagos, Nigeria
    • Federal Medical Center
• Peru
  • Lima, Peru
    • Instituto Nacional de Enfermedades Neoplasicas
  • Lima, Peru
    • Universidad Peruana Cayetano Heredia
• Poland
  • Publin, Poland
    • University of Lublin
  • Wroclaw, Poland
    • Wroclaw Medical Center
• Portugal
  • Lisbon, Portugal
    • Instituto Nacional de Saúde Dr. Ricardo Jorge
  • Porto, Portugal
    • University of Porto
• Puerto Rico
  • San Juan, Puerto Rico
    • University of Puerto Rico
• Russian Federation
  • Moscow, Russian Federation
    • Clinical Research Center of Moscow
• Singapore
  • Singapore, Singapore
    • National University Hospital
• South Africa
  • Soweto, South Africa
    • Chris Hani Baragwanath Academic Hospital
• Spain
  • Barcelona, Spain
    • Hospital Clinic De Barcelona
  • Barcelona, Spain
    • Hospital General de Granollers
  • Barcelona, Spain
    • Hospital Universitari Parc Tauli
  • Barcelona, Spain
    • Institut d'Investigació Biomédica de Bellvitge (Idibell)
  • Barcelona, Spain
    • L'Hospitalet de Llobregat
  • León, Spain
    • Hospital de Leon
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain
    • Hospital De La Princesa
  • Oviedo, Spain
    • Hospital Universitario de Asturias
  • Pamplona, Spain
    • Complejo Hospitalario de Navarra
  • San Sebastian, Spain
    • Hospital Donostia
  • Zaragoza, Spain
    • Lozano Blesa University Hospital
• Sudan
  • Khartoum, Sudan
    • Sudan University of Science and Technology
• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet
• Switzerland
  • Bern, Switzerland
    • University of Bern
  • Zurich, Switzerland
    • University of Zurich
• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
• Turkey
  • Istanbul, Turkey
    • Istanbul University
• United States
  • Arkansas
    • Batesville, Arkansas, United States
      • White River Medical Center
  • California
    • Stanford, California, United States
      • Stanford University
  • Georgia
    • Athens, Georgia, United States
      • Georgia Cancer Center Biorepository
    • Atlanta, Georgia, United States
      • Centers for Disease Control and Prevention
  • New York
    • Bronx, New York, United States
      • Albert Einstein College of Medicine
  • Tennessee
    • Nashville, Tennessee, United States
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States
      • Baylor College of Medicine
• Vietnam
  • Ho Chi Minh City, Vietnam
    • Cho Ray Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

H. pylori strains from patients with various gastrointestinal diseases.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial DNA sequence	genome and methylome	At enrollment

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Collaborators: Karolinska Institutet; Vanderbilt University Medical Center, USA; 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; University of Tokyo, Japan; Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany; Universidad de Chile, Chile; HOSEI University, Japan
• Investigators: Principal Investigator: Charles S. Rabkin, M.D., National Cancer Institute (NCI); Principal Investigator: M. Constanza Camargo, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Correa P, Haenszel W, Cuello C, Tannenbaum S, Archer M. A model for gastric cancer epidemiology. Lancet. 1975 Jul 12;2(7924):58-60. doi: 10.1016/s0140-6736(75)90498-5.
• Tomb JF, White O, Kerlavage AR, Clayton RA, Sutton GG, Fleischmann RD, Ketchum KA, Klenk HP, Gill S, Dougherty BA, Nelson K, Quackenbush J, Zhou L, Kirkness EF, Peterson S, Loftus B, Richardson D, Dodson R, Khalak HG, Glodek A, McKenney K, Fitzegerald LM, Lee N, Adams MD, Hickey EK, Berg DE, Gocayne JD, Utterback TR, Peterson JD, Kelley JM, Cotton MD, Weidman JM, Fujii C, Bowman C, Watthey L, Wallin E, Hayes WS, Borodovsky M, Karp PD, Smith HO, Fraser CM, Venter JC. The complete genome sequence of the gastric pathogen Helicobacter pylori. Nature. 1997 Aug 7;388(6642):539-47. doi: 10.1038/41483. Erratum In: Nature 1997 Sep 25;389(6649):412.
• Krebes J, Morgan RD, Bunk B, Sproer C, Luong K, Parusel R, Anton BP, Konig C, Josenhans C, Overmann J, Roberts RJ, Korlach J, Suerbaum S. The complex methylome of the human gastric pathogen Helicobacter pylori. Nucleic Acids Res. 2014 Feb;42(4):2415-32. doi: 10.1093/nar/gkt1201. Epub 2013 Dec 2.

Helpful Links

• HpGP webpage

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2016
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: May 28, 2016
• First Submitted That Met QC Criteria: May 28, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Gastric Cancer; Biobank; DNA Methylation; Bacterial Risk Factors; DNA Sequencing; SMRT/PacBio
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Stomach Neoplasms; Gastritis; Metaplasia
• Other Study ID Numbers: NCI-2020-07069; 16-C-N120; 999916120 (Other Identifier: National Cancer Institute)