Helicobacter Pylori Genome Project (HpGP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02788214|
Recruitment Status : Terminated (research determined not to be human subject research)
First Posted : June 2, 2016
Last Update Posted : December 19, 2020
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.
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.
People ages 30-70 years who need an upper endoscopy or who were recently diagnosed with stomach cancer
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.
|Condition or disease|
|Gastric Cancer Non-Atrophic Gastritis Intestinal Metaplasia|
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Helicobacter Pylori Genome Project (HpGP)|
|Actual Study Start Date :||July 27, 2016|
|Actual Primary Completion Date :||May 15, 2020|
|Actual Study Completion Date :||May 15, 2020|
Advanced intestinal metaplasia
H. pylori strains from patients with:
H. pylori strains from patients with non-atrophic gastritis
H. pylori strains from patients with gastric cancer
- Bacterial DNA sequence [ Time Frame: At enrollment ]genome and methylome
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788214
|Principal Investigator:||Charles S. Rabkin, M.D.||National Cancer Institute (NCI)|
|Principal Investigator:||M. Constanza Camargo, Ph.D.||National Cancer Institute (NCI)|