Study Stopped
research determined not to be human subject research
Helicobacter Pylori Genome Project (HpGP)
3 other identifiers
observational
1,000
49 countries
88
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Typical duration for all trials
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedStudy Start
First participant enrolled
July 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2020
CompletedDecember 19, 2020
December 1, 2020
3.8 years
May 28, 2016
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bacterial DNA sequence
genome and methylome
At enrollment
Study Arms (3)
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
Eligibility Criteria
H. pylori strains from patients with various gastrointestinal diseases.
You may qualify if:
- H. pylori strains collected from:
- Adult aged 30 to 70 years old.
- Patients who need upper endoscopy (examination of the lining of their stomach with a flexible tube).
- Patients with stomach cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- New England Biolabs, USAcollaborator
- National Institute of Infectious Diseases, Japancollaborator
- National Institute of Genetics, Japancollaborator
- Chiba University, Japancollaborator
- National Institute for Basic Biology, Japancollaborator
- Instituto Mexicano del Seguro Socialcollaborator
- Universidade de Lisboa, Portugalcollaborator
- Instituto de Biomedicina de Valencia, Spaincollaborator
- University of Bath, UKcollaborator
- Vanderbilt University Medical Center, USAcollaborator
- Karolinska Institutetcollaborator
- University of Tokyo, Japancollaborator
- Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germanycollaborator
- Universidad de Chile, Chilecollaborator
- HOSEI University, Japancollaborator
Study Sites (94)
White River Medical Center
Batesville, Arkansas, United States
Stanford University
Stanford, California, United States
Georgia Cancer Center Biorepository
Athens, Georgia, United States
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Université Ferhat Abbas
Sétif, Algeria
Hospital Alemán
Buenos Aires, Argentina
Dhaka Medical College and Hospital
Dhaka, Bangladesh
Ghent University
Ghent, Belgium
Universidade Federal de Minas Gerais
Belo Horizonte, Brazil
AC Camargo Cancer Center
São Paulo, Brazil
Medical University of Sofia
Sofia, Bulgaria
Tsaritsa Yoanna University Hospital
Sofia, Bulgaria
Defence Services General Hospital
Yangon, Burma
University of Dschang
Dschang, Cameroon
University of Alberta
Edmonton, Canada
Universidad de Concepción
Concepción, Chile
Hospital Hanga Roa
Easter Island, Chile
Pontificia Universidad Catolica
Santiago, Chile
Instituto Nacional de Cancerología
Bogotá, Colombia
Universidad del Valle
Cali, Colombia
Universidad de Nariño
Pasto, Colombia
Universidad de Costa Rica
San José, Costa Rica
University of Kinshasa
Kinshasa, Democratic Republic of the Congo
University of Mbuji Mayi
Mbuji-Mayi, Democratic Republic of the Congo
Universidad Autónoma de Santo Domingo
Santo Domingo, Dominican Republic
C.H.U. Pellegrin
Bordeaux, France
Otto-von-Guericke Universitätsklinikum
Magdeburg, Germany
University of Cape Coast
Cape Coast, Ghana
Evangelismos Hospital and Hellenic Pasteur Institute
Athens, Greece
Hellenic Pasteur Institute
Athens, Greece
Universidad San Carlos
Guatemala City, Guatemala
Hospital de Occidente
Santa Rosa de Copán, Honduras
National University Hospital
Reykjavik, Iceland
Kasturba Medical College Manipal
Manipal, India
University of Indonesia
Depok, Indonesia
Universitas Airlangga
Surabaya, Indonesia
Digestive Disease Research Institute
Tehran, Iran
Bar Ilan University
Ramat Gan, Israel
Centro di Rferimento Oncologico
Aviano, Italy
Nagoya City University
Nagoya, Japan
Oita University
Ōita, Japan
HOSEI University
Tokyo, Japan
Kyorin University
Tokyo, Japan
Nippon Medical School
Tokyo, Japan
Jordan University of Science and Technology
Ar Ramtha, Jordan
Central Asian Cancer Institute
Almaty, Kazakhstan
Tenwek Hospital
Bomet, Kenya
Kyrgyz State Medical Academy
Bishkek, Kyrgyzstan
University of Latvia
Riga, Latvia
Lithuanian University of Health Sciences
Kaunas, Lithuania
University of Malaya
Kuala Lumpur, Malaysia
Instituto Nacional de Cancerología
Mexico City, Mexico
Chitwan Medical College
Bharatpur, Nepal
Tribhuvan University Teaching Hospital
Kathmandu, Nepal
University of Calabar Teaching Hospital
Calabar, Nigeria
University of Nigeria Teaching Hospital
Enugu, Nigeria
Babcock Universtiy Teaching Hospital
Ilishan, Nigeria
University of Jos / University Teaching Hospital
Jos, Nigeria
Federal Medical Center
Lagos, Nigeria
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru
Universidad Peruana Cayetano Heredia
Lima, Peru
University of Lublin
Publin, Poland
Wroclaw Medical Center
Wroclaw, Poland
Instituto Nacional de Saúde Dr. Ricardo Jorge
Lisbon, Portugal
University of Porto
Porto, Portugal
University of Puerto Rico
San Juan, Puerto Rico
Clinical Research Center of Moscow
Moscow, Russia
National University Hospital
Singapore, Singapore
Chris Hani Baragwanath Academic Hospital
Soweto, South Africa
Seoul National University Bundang Hospital
Seongnam, South Korea
Chung-Ang University Hospital
Seoul, South Korea
National Cancer Center
Seoul, South Korea
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
Barcelona, Spain
Hospital Donostia
Donostia / San Sebastian, Spain
Hospital de Leon
León, Spain
Hospital de la Princesa
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario de Asturias
Oviedo, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Lozano Blesa University Hospital
Zaragoza, Spain
Sudan University of Science and Technology
Khartoum, Sudan
Karolinska Institutet
Stockholm, Sweden
University of Bern
Bern, Switzerland
University of Zurich
Zurich, Switzerland
National Taiwan University Hospital
Taipei, Taiwan
Istanbul University
Istanbul, Turkey (Türkiye)
Cho Ray Hospital
Ho Chi Minh City, Vietnam
Related Publications (3)
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.
PMID: 49653BACKGROUNDTomb 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.
PMID: 9252185BACKGROUNDKrebes 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.
PMID: 24302578BACKGROUND
Related Links
Biospecimen
Helicobacter pylori strains.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles S. Rabkin, M.D.
National Cancer Institute (NCI)
- PRINCIPAL INVESTIGATOR
M. Constanza Camargo, Ph.D.
National Cancer Institute (NCI)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2016
First Posted
June 2, 2016
Study Start
July 27, 2016
Primary Completion
May 15, 2020
Study Completion
May 15, 2020
Last Updated
December 19, 2020
Record last verified: 2020-12