Helicobacter Pylori Genome Project (HpGP)
- Conditions
- Non-Atrophic GastritisIntestinal MetaplasiaGastric Cancer
- Registration Number
- NCT02788214
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bacterial DNA sequence At enrollment genome and methylome
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (92)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Indonesia
🇮🇩Kota Depok, Indonesia
Digestive Disease Research Institute
🇮🇷Teheran, Iran, Islamic Republic of
Nagoya City University
🇯🇵Nagoya, Japan
Université Ferhat Abbas
🇩🇿Sétif, Algeria
Hospital Alemán
🇦🇷Buenos Aires, Argentina
Medical University of Sofia
🇧🇬Sofia, Bulgaria
University of Alberta
🇨🇦Edmonton, Canada
AC Camargo Cancer Center
🇧🇷Sao Paulo, Brazil
Tsaritsa Yoanna University Hospital
🇧🇬Sofia, Bulgaria
Universidad del Valle
🇨🇴Cali, Colombia
University of Dschang
🇨🇲Dschang, Cameroon
Universidad de Nariño
🇨🇴Pasto, Colombia
Universidad de Costa Rica
🇨🇷San José, Costa Rica
Universidad Autónoma de Santo Domingo
🇩🇴Santo Domingo, Dominican Republic
University of Malaya
🇲🇾Kuala Lumpur, Malaysia
Universidad de Concepción
🇨🇱Concepción, Chile
Hospital Hanga Roa
🇨🇱Easter Island, Chile
C.H.U. Pellegrin
🇫🇷Bordeaux, France
Otto-von-Guericke Universitätsklinikum
🇩🇪Magdeburg, Germany
Hellenic Pasteur Institute
🇬🇷Athens, Greece
Pontificia Universidad Catolica
🇨🇱Santiago, Chile
Instituto Nacional de Cancerología
🇲🇽Mexico City, Mexico
University of Cape Coast
🇬🇭Cape Coast, Ghana
Evangelismos Hospital and Hellenic Pasteur Institute
🇬🇷Athens, Greece
Universitas Airlangga
🇮🇩Kota Surabaya, Indonesia
Nippon Medical School
🇯🇵Tokyo, Japan
Oita University
🇯🇵Ōita, Japan
Jordan University of Science and Technology
🇯🇴Ramtha, Jordan
Tenwek Hospital
🇰🇪Bomet, Kenya
Chitwan Medical College
🇳🇵Bharatpur, Nepal
University of Jos / University Teaching Hospital
🇳🇬Jos, Nigeria
Hospital Universitari Parc Tauli
🇪🇸Barcelona, Spain
Chris Hani Baragwanath Academic Hospital
🇿🇦Soweto, South Africa
Hospital de la Princesa
🇪🇸Madrid, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Donostia
🇪🇸San Sebastian, Spain
Hospital Universitario de Asturias
🇪🇸Oviedo, 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
Cho Ray Hospital
🇻🇳Ho Chi Minh City, Vietnam
Clinical Research Center of Moscow
🇷🇺Moscow, Russian Federation
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
L'Hospitalet de Llobregat
🇪🇸Barcelona, Spain
Dhaka Medical College and Hospital
🇧🇩Dhaka, Bangladesh
Ghent University
🇧🇪Ghent, Belgium
Universidade Federal de Minas Gerais
🇧🇷Belo Horizonte, Brazil
White River Medical Center
🇺🇸Batesville, Arkansas, United States
Stanford University
🇺🇸Stanford, California, United States
Georgia Cancer Center Biorepository
🇺🇸Athens, Georgia, United States
University of Kinshasa
🇨🇩Kinshasa, Congo, The Democratic Republic of the
University of Mbuji Mayi
🇨🇩Mbuji-Mayi, Congo, The Democratic Republic of the
Universidad San Carlos
🇬🇹Guatemala, Guatemala
Hospital de Occidente
🇭🇳Santa Rosa De Copán, Honduras
National University Hospital
🇸🇬Singapore, Singapore
Kasturba Medical College Manipal
🇮🇳Manipal, India
Bar Ilan University
🇮🇱Ramat Gan, Israel
Centro di Rferimento Oncologico
🇮🇹Aviano, Italy
HOSEI University
🇯🇵Tokyo, Japan
Kyorin University
🇯🇵Tokyo, Japan
Central Asian Cancer Institute
🇰🇿Almaty, Kazakhstan
Kyrgyz State Medical Academy
🇰🇬Bishkek, Kyrgyzstan
University of Latvia
🇱🇻Riga, Latvia
Babcock Universtiy Teaching Hospital
🇳🇬Ilishan-Remo, Nigeria
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Universidad Peruana Cayetano Heredia
🇵🇪Lima, Peru
University of Lublin
🇵🇱Publin, Poland
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
Hospital de Leon
🇪🇸León, Spain
University of Calabar Teaching Hospital
🇳🇬Calabar, Nigeria
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Lithuanian University of Health Sciences
🇱🇹Kaunas, Lithuania
Defence Services General Hospital
🇲🇲Yangon, Myanmar
Tribhuvan University Teaching Hospital
🇳🇵Kathmandu, Nepal
University of Nigeria Teaching Hospital
🇳🇬Enugu, Nigeria
Federal Medical Center
🇳🇬Lagos, Nigeria
Wroclaw Medical Center
🇵🇱Wroclaw, Poland
Instituto Nacional de Saúde Dr. Ricardo Jorge
🇵🇹Lisbon, Portugal
University of Porto
🇵🇹Porto, Portugal
Istanbul University
🇹🇷Istanbul, Turkey
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Seoul, Korea, Republic of
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Institut d'Investigació Biomédica de Bellvitge (Idibell)
🇪🇸Barcelona, Spain
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Hospital General de Granollers
🇪🇸Barcelona, Spain
Centers for Disease Control and Prevention
🇺🇸Atlanta, Georgia, United States