Helicobacter Pylori Genome Project (HpGP)

Gastric Cancer Clinical Trial

Official title:

Helicobacter Pylori Genome Project (HpGP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02788214
• Other study ID #: NCI-2020-07069
• Secondary ID: 16-C-N1209999161
• Status: Terminated
• Start date: July 27, 2016
• Est. completion date: May 15, 2020

Study information

• Verified date: December 2020
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Gastritis
• Intestinal Metaplasia
• Metaplasia
• Non-Atrophic Gastritis
• Stomach Neoplasms

Locations

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

Sponsors (16)

Lead Sponsor

Collaborator

National Cancer Institute (NCI)

Chiba University, Japan, HOSEI University, Japan, Instituto de Biomedicina de Valencia, Spain, Instituto Mexicano de Seguro Social, Mexico, Karolinska Institutet, Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany, National Institute for Basic Biology, Japan, National Institute of Genetics, Japan, National Institute of Infectious Diseases, Japan, New England Biolabs, USA, Universidad de Chile, Chile, Universidade de Lisboa, Portugal, University of Bath, UK, University of Tokyo, Japan, Vanderbilt University Medical Center, USA

Countries where clinical trial is conducted

United States,  Vietnam,  Algeria,  Argentina,  Bangladesh,  Belgium,  Brazil,  Bulgaria,  Cameroon,  Canada,  Chile,  Colombia,  Congo, The Democratic Republic of the,  Costa Rica,  Dominican Republic,  France,  Germany,  Ghana,  Greece,  Guatemala,  Honduras,  Iceland,  India,  Indonesia,  Iran, Islamic Republic of,  Israel,  Italy,  Japan,  Jordan,  Kazakhstan,  Kenya,  Korea, Republic of,  Kyrgyzstan,  Latvia,  Lithuania,  Malaysia,  Mexico,  Myanmar,  Nepal,  Nigeria,  Peru,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Singapore,  South Africa,  Spain,  Sudan,  Sweden,  Switzerland,  Taiwan,  Turkey, 

References & 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. — View Citation

Krebes J, Morgan RD, Bunk B, Spröer C, Luong K, Parusel R, Anton BP, König 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. — View 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. Erratum in: Nature 1997 Sep 25;389(6649):412. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial DNA sequence	genome and methylome	At enrollment

External Links

•   HpGP webpage