Clinical trial NCT02788214: Helicobacter Pylori Genome Project (HpGP)
Official title: Helicobacter Pylori Genome Project (HpGP)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastric Cancer
Non-Atrophic Gastritis
Intestinal Metaplasia
Keywords: Gastric Cancer
Bacterial Risk Factors
DNA Methylation
DNA Sequencing
Biobank
Helicobacter pylori
SMRT/PacBio
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: New England Biolabs, USA
name: National Institute of Infectious Diseases, Japan
name: National Institute of Genetics, Japan
name: Chiba University, Japan
name: National Institute for Basic Biology, Japan
name: Instituto Mexicano de Seguro Social, Mexico
name: Universidade de Lisboa, Portugal
name: Instituto de Biomedicina de Valencia, Spain
name: University of Bath, UK
name: Vanderbilt University Medical Center, USA
name: Karolinska Institutet
name: University of Tokyo, Japan
name: Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany
name: Universidad de Chile, Chile
name: HOSEI University, Japan
First posted: 2016-06-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: H. pylori strains from patients with various gastrointestinal diseases.

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.

Eligibility 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.

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