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.
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.
Brief Title
Helicobacter Pylori Genome Project (HpGP)
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Gastric Cancer
Non-Atrophic Gastritis
Intestinal Metaplasia
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Keywords
Gastric Cancer
Bacterial Risk Factors
DNA Methylation
DNA Sequencing
Biobank
Helicobacter pylori
SMRT/PacBio
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
30 Years
NCT Id
NCT02788214
Org Class
Nih
Org Full Name
National Cancer Institute (NCI)
Org Study Id
NCI-2020-07069
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Helicobacter Pylori Genome Project (HpGP)
Primary Outcomes
Outcome Description
genome and methylome
Outcome Measure
Bacterial DNA sequence
Outcome Time Frame
At enrollment
Secondary Ids
Secondary Id
16-C-N120
Secondary Id
999916120
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
H. pylori strains from patients with various gastrointestinal diseases.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
30
Investigators
Investigator Type
Principal Investigator
Investigator Name
Haejin In
Investigator Email
hin@montefiore.org
Investigator Phone
929-246-6726