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Screening for Gastric Cancer in High-risk Population (Stomach)

This study is currently recruiting participants.
Verified December 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Yaron Niv, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00815113
First received: December 25, 2008
Last updated: December 2, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Gastric Cancer in High-risk Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Characterization of the high-rik individual for gastric cancer - "Gastric Cancer Phenotype" [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Gastric biopsies


Estimated Enrollment: 450
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)
Groups/Cohorts
1
First degree relative of gastric cancer patient
2
Consecutive gastro-esophageal reflux patients

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

First degree relatives of gastric cancer patients

Criteria

Inclusion Criteria:

  1. First relative, man or woman, of gastric cancer patients.
  2. Signed informed consent.
  3. Age 18-60.

Exclusion Criteria:

  1. Severe back ground disease.
  2. State after gastric surgery.
  3. COPD, CHF, CRF and any disease with respiratory disturbances.
  4. Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815113

Contacts
Contact: Tami lederfien, BSc 97239377040 tamila@clalit.org.il
Contact: Yaron Niv, MD 97239377237 yniv@clalit.org.il

Locations
Israel
Department of Gastroenterology, Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Tami Lederfein, BSc     97239377040     tamila@clalit.org.il    
Contact: Yaron Niv, MD     97239377237     yniv@clalit.org.il    
Principal Investigator: Yaron Niv, MD            
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Yaron Niv, MD RMC
  More Information

No publications provided

Responsible Party: Yaron Niv, Director Department of Gastroenterology, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00815113     History of Changes
Other Study ID Numbers: RMC080000CTIL
Study First Received: December 25, 2008
Last Updated: December 2, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Gastric cancer
screening
high-risk
relatives
gastroscopy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 23, 2013