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

This study is currently recruiting participants.
Verified September 2017 by Yaron Niv, Rabin Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815113
First Posted: December 29, 2008
Last Update Posted: September 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yaron Niv, Rabin Medical Center
  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:


Further study details as provided by Yaron Niv, Rabin Medical Center:

Primary Outcome Measures:
  • Characterization of the high-rik individual for gastric cancer - "Gastric Cancer Phenotype" [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Establish a screen plan for high-risk population for gastric cancer [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Gastric biopsies

Estimated Enrollment: 200
Actual Study Start Date: October 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Responsible Party: Yaron Niv, Director Department of Gastroenterology, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00815113     History of Changes
Other Study ID Numbers: RMC080000CTIL
First Submitted: December 25, 2008
First Posted: December 29, 2008
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Yaron Niv, 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