Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1000 participants
OBSERVATIONAL
2016-07-27
2020-05-15
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
No interventions assigned to this group
Non-atrophic gastritis
H. pylori strains from patients with non-atrophic gastritis
No interventions assigned to this group
Gastric cancer
H. pylori strains from patients with gastric cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
30 Years
70 Years
ALL
No
Sponsors
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New England Biolabs, USA
UNKNOWN
National Institute of Infectious Diseases, Japan
UNKNOWN
National Institute of Genetics, Japan
UNKNOWN
Chiba University, Japan
UNKNOWN
National Institute for Basic Biology, Japan
UNKNOWN
Instituto Mexicano del Seguro Social
OTHER_GOV
Universidade de Lisboa, Portugal
UNKNOWN
Instituto de Biomedicina de Valencia, Spain
UNKNOWN
University of Bath, UK
UNKNOWN
Vanderbilt University Medical Center, USA
UNKNOWN
Karolinska Institutet
OTHER
University of Tokyo, Japan
UNKNOWN
Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany
UNKNOWN
Universidad de Chile, Chile
UNKNOWN
HOSEI University, Japan
UNKNOWN
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Charles S. Rabkin, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
M. Constanza Camargo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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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
Countries
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References
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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.
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.
Related Links
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Other Identifiers
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16-C-N120
Identifier Type: -
Identifier Source: secondary_id
999916120
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2020-07069
Identifier Type: -
Identifier Source: org_study_id