Helicobacter Pylori Genome Project
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 35 - 70 |
| Updated: | 11/11/2018 |
| Start Date: | July 27, 2016 |
| End Date: | September 30, 2020 |
| Contact: | Charles S Rabkin, M.D. |
| Email: | rabkinc@epndce.nci.nih.gov |
| Phone: | (240) 276-7105 |
Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems
or stomach cancer. Researchers want to look at samples of the bacteria. These will be taken
from chronically infected people. They want to identify the genetic differences in H. pylori
strains. This could help predict which people who get infected with the bacteria will get
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 35 70 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.
or stomach cancer. Researchers want to look at samples of the bacteria. These will be taken
from chronically infected people. They want to identify the genetic differences in H. pylori
strains. This could help predict which people who get infected with the bacteria will get
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 35 70 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.
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/FNLCR. 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.
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/FNLCR. 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.
- INCLUSION CRITERIA:
1. Adult aged 35 to 70 years old.
2. Patients who need upper endoscopy (examination of the lining of their stomach
with a flexible tube).
3. Patients recently diagnosed with stomach cancer.
We found this trial at
5
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
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