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Screening for Gastric Cancer in High-risk Population

NCT00815113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2018-04-11

No results posted yet for this study

Summary

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.

Aims:

1. To characterize the high risk individual for gastric cancer development.
2. To establish a screening plan for early detection and prevention of gastric cancer in first degree relatives of gastric cancer patients.
3. 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 \[serology, histology, urease test, 13C-urea breath test (13C-UBT)\].
4. To assess genetic changes in the gastric mucosa of the screenees in comparison with gastric cancer patients and controls.

Methods:

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.

Conditions

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Yaron Niv, MD · RMC

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815113 on ClinicalTrials.gov