Helicobacter Pylori Genome Project (HpGP) | NCT02788214

Studies
Helicobacter Pylori Genome Project (HpGP)

NCT02788214

Sponsor

National Cancer Institute (NCI)

Status

Terminated

Last Update Posted

Dec 19, 2020Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Gastric Cancer
Non-Atrophic Gastritis
Intestinal Metaplasia

Interventions

Not provided

Countries

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

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
16-C-N120
999916120	Other Identifier	National Cancer Institute

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

research determined not to be human subject research

Expanded Access Info

Start Date

Jul 27, 2016Actual

Primary Completion Date

May 15, 2020Actual

Completion Date

May 15, 2020Actual

First Submitted Date

May 28, 2016

First Submission Date that Met QC Criteria

May 28, 2016

First Posted Date

Jun 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

National Cancer Institute (NCI)NIH

Collaborators

Name	Class
New England Biolabs, USA	UNKNOWN
National Institute of Infectious Diseases, Japan	UNKNOWN
National Institute of Genetics, Japan	UNKNOWN
Chiba University, Japan

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bacterial DNA sequence	genome and methylome	At enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

H. 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

H. pylori strains from patients with various gastrointestinal diseases.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles S. Rabkin, M.D.	National Cancer Institute (NCI)	Principal Investigator
M. Constanza Camargo, Ph.D.	National Cancer Institute (NCI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
White River Medical Center		Batesville	Arkansas		United States
Stanford University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
49653	Background	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.
9252185	Background	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.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases