Gastric CancerNCT02788214
Helicobacter Pylori Genome Project (HpGP)
An observational study of Gastric Cancer and Non-Atrophic Gastritis, run by National Cancer Institute (NCI) at 94 sites in 53 countries.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Gastric Cancer, Non-Atrophic Gastritis, Intestinal Metaplasia
- How many people
- 1,000 participants
- Where
- 94 sitesin 53 countries
- Study dates
- 27 Jul 2016to 15 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: H. pylori strains from patients with various gastrointestinal diseases.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
94 sites in 53 countries.
94 sites in 53 countries
Spain12 sites
Hospital Clinic de Barcelona
Barcelona
Hospital General de Granollers
Barcelona
Hospital Universitari Parc Tauli
Barcelona
Institut d'Investigació Biomédica de Bellvitge (Idibell)
Barcelona
L'Hospitalet de Llobregat
Barcelona
Hospital Donostia
Donostia / San Sebastian
Hospital de Leon
León
Hospital de la Princesa
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario de Asturias
Oviedo
Complejo Hospitalario de Navarra
Pamplona
Lozano Blesa University Hospital
Zaragoza
United States7 sites
Georgia Cancer Center Biorepository
Athens, Georgia
Centers for Disease Control and Prevention
Atlanta, Georgia
White River Medical Center
Batesville, Arkansas
Baylor College of Medicine
Houston, Texas
Vanderbilt University Medical Center
Nashville, Tennessee
Stanford University
Stanford, California
Albert Einstein College of Medicine
The Bronx, New York
Japan5 sites
Nagoya City University
Nagoya
Oita University
Ōita
HOSEI University
Tokyo
Kyorin University
Tokyo
Nippon Medical School
Tokyo
Nigeria5 sites
University of Calabar Teaching Hospital
Calabar
University of Nigeria Teaching Hospital
Enugu
Babcock Universtiy Teaching Hospital
Ilishan
University of Jos / University Teaching Hospital
Jos
Federal Medical Center
Lagos
Chile3 sites
Universidad de Concepción
Concepción
Hospital Hanga Roa
Easter Island
Pontificia Universidad Catolica
Santiago
Colombia3 sites
Instituto Nacional de Cancerología
Bogotá
Universidad del Valle
Cali
Universidad de Nariño
Pasto
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam
Chung-Ang University Hospital
Seoul
National Cancer Center
Seoul
Brazil2 sites
Universidade Federal de Minas Gerais
Belo Horizonte
AC Camargo Cancer Center
São Paulo
Bulgaria2 sites
Medical University of Sofia
Sofia
Tsaritsa Yoanna University Hospital
Sofia
Democratic Republic of the Congo2 sites
University of Kinshasa
Kinshasa
University of Mbuji Mayi
Mbuji-Mayi
Greece2 sites
Evangelismos Hospital and Hellenic Pasteur Institute
Athens
Hellenic Pasteur Institute
Athens
Indonesia2 sites
University of Indonesia
Depok
Universitas Airlangga
Surabaya
Nepal2 sites
Chitwan Medical College
Bharatpur
Tribhuvan University Teaching Hospital
Kathmandu
Peru2 sites
Instituto Nacional de Enfermedades Neoplasicas
Lima
Universidad Peruana Cayetano Heredia
Lima
Portugal2 sites
Instituto Nacional de Saúde Dr. Ricardo Jorge
Lisbon
University of Porto
Porto
Dominican Republic1 site
Universidad Autónoma de Santo Domingo
Santo Domingo
About this study
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:
Read more
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.
Read the 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.
- Keywords
- Gastric Cancer, Bacterial Risk Factors, DNA Methylation, DNA Sequencing, Biobank, Helicobacter pylori, SMRT/PacBio
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial DNA sequence
genome and methylome
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start27 Jul 2016
- Primary completion15 May 2020
- Study completion15 May 2020
Why it stopped: research determined not to be human subject research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- New England Biolabs, USA, National Institute of Infectious Diseases, Japan, National Institute of Genetics, Japan, Chiba University, Japan, National Institute for Basic Biology, Japan, Instituto Mexicano del Seguro Social, Universidade de Lisboa, Portugal, Instituto de Biomedicina de Valencia, Spain, University of Bath, Vanderbilt University Medical Center, Karolinska Institutet, University of Tokyo, Japan, Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany, University of Chile, HOSEI University, Japan
- Responsible party
- Sponsor
- Investigators
- Charles S. Rabkin, M.D., Principal investigator, National Cancer Institute (NCI)M. Constanza Camargo, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788214
- Sponsor's protocol ID
- NCI-2020-07069
- Other IDs
- 16-C-N120, 999916120
- Status last verified
- Dec 2020
- First submitted
- 28 May 2016
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
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.
PubMed 49653Tomb 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.
PubMed 9252185Krebes 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.
PubMed 24302578
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Genome Project (HpGP)
- ClinicalTrials.gov ID
- NCT02788214
- Acronym / sponsor ID
- NCI-2020-07069
- Keywords
- Gastric Cancer, Bacterial Risk Factors, DNA Methylation, DNA Sequencing, Biobank, Helicobacter pylori, SMRT/PacBio
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: research determined not to be human subject research
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- New England Biolabs, USA, National Institute of Infectious Diseases, Japan, National Institute of Genetics, Japan, Chiba University, Japan, National Institute for Basic Biology, Japan, Instituto Mexicano del Seguro Social, Universidade de Lisboa, Portugal, Instituto de Biomedicina de Valencia, Spain, University of Bath, Vanderbilt University Medical Center, Karolinska Institutet, University of Tokyo, Japan, Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany, University of Chile, HOSEI University, Japan
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- H. pylori strains from patients with various gastrointestinal diseases.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial DNA sequence
Time frame: At enrollment
genome and methylome
Results and safety
The study was stopped early (reason given: research determined not to be human subject research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Background: PubMed 49653Correa 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.
- Background: PubMed 9252185Tomb 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.
- Background: PubMed 24302578Krebes 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.
- HpGP webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles S. Rabkin, M.D. principal investigator
National Cancer Institute (NCI)
M. Constanza Camargo, Ph.D. principal investigator
National Cancer Institute (NCI)
94 sites in 53 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Non-Atrophic Gastritis, run by National Cancer Institute (NCI) at 94 sites in 53 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in Spain, United States, Japan, Nigeria, Chile and 48 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: research determined not to be human subject research). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial DNA sequence (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788214, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.