An observational study in Gastric Cancer, Non-Atrophic Gastritis and Intestinal Metaplasia, sponsored by National Cancer Institute (NCI). Terminated at 94 sites in 53 countries. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by National Cancer Institute (NCI) · Observational
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.
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 1,000 is above the median of 278 across 790 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
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H. pylori strains from patients with various gastrointestinal diseases.
INCLUSION CRITERIA:
H. pylori strains collected from:
H. pylori strains from patients with: * Complete-type intestinal metaplasia with extension to corpus, or * Incomplete-type intestinal metaplasia of any extent
H. pylori strains from patients with non-atrophic gastritis
H. pylori strains from patients with gastric cancer
Bacterial DNA sequence
genome and methylome
Time frame: At enrollment
Ran from Jul 2016 to primary completion in May 2020, 45 months.
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This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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