Screening for Gastric Cancer in High-risk Population (Stomach)
Recruitment status was: Recruiting
Introduction: Gastric cancer is the world's second largest cause of cancer related deaths. In the Western world, as well as in Israel, this malignancy is less prevalent than colorectal cancer, but has higher morbidity and mortality. First degree relatives of patients with gastric cancer have a 1.5-fold to 3-fold increased risk of developing gastric cancer themselves. In relatives of gastric cancer patients who are also carriers of a CagA positive strain of Helicobacter pylori, the risk is 8-fold. Mucosal atrophy, hypochlorhydria, high lymphoid follicle density, pan gastritis, and interleukin 1 β polymorphism are frequent in family members of gastric cancer patients and are associated with increased risk of the disease.
- To characterize the high risk individual for gastric cancer development.
- To establish a screening plan for early detection and prevention of gastric cancer in first degree relatives of gastric cancer patients.
- To validate new procedures for assessing risk factors for development of gastric cancer: gastric acid output, gastric mucin output, serum levels of pepsinogen I, pepsinogen II, gastrin B12, Helicobacter pylori status [serology, histology, urease test, 13C-urea breath test (13C-UBT)].
- To assess genetic changes in the gastric mucosa of the screenees in comparison with gastric cancer patients and controls.
We will approach 50 gastric cancer patients treated in Rabin Medical Center, and ask for their consent to approach first degree relatives for participating in the study. For each gastric cancer patient 4 relatives will be asked to signed an informed consent and undergo the study procedures. For each participant a matched control for age, sex and background diseases, out of consecutive gastro esophageal reflux disease (GERD) patients undergoing gastroscopy, will be asked to join the study. Thus, we will screen 50 gastric cancer patients, 200 first degree relatives of gastric cancer patients, and 200 controls.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Screening for Gastric Cancer in High-risk Population|
- Characterization of the high-rik individual for gastric cancer - "Gastric Cancer Phenotype" [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Establish a screen plan for high-risk population for gastric cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
First degree relative of gastric cancer patient
Consecutive gastro-esophageal reflux patients
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00815113
|Department of Gastroenterology, Rabin Medical Center|
|Petach Tikva, Israel, 49100|
|Principal Investigator:||Yaron Niv, MD||RMC|