Screening for Gastric Cancer in High-risk Population

NCT00815113 | Completed DMC

• 1 other identifier: RMC080000CTIL
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.To characterize the high risk individual for gastric cancer development.
2. 2.To establish a screening plan for early detection and prevention of gastric cancer in first degree relatives of gastric cancer patients.
3. 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. 4.To assess genetic changes in the gastric mucosa of the screenees in comparison with gastric cancer patients and controls.

Conditions

Gastric Cancer

Keywords

Gastric cancer; screening; high-risk; relatives; gastroscopy

Outcome Measures

Primary Outcomes (1)

• Characterization of the high-rik individual for gastric cancer - "Gastric Cancer Phenotype"

  2 years

Secondary Outcomes (1)

• Establish a screen plan for high-risk population for gastric cancer

  2 years

Study Arms (2)

1

First degree relative of gastric cancer patient

2

Consecutive gastro-esophageal reflux patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

First degree relatives of gastric cancer patients

You may qualify if:

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

You may not qualify if:

• Severe back ground disease.
• State after gastric surgery.
• COPD, CHF, CRF and any disease with respiratory disturbances.
• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Department of Gastroenterology, Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gastric biopsies

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yaron Niv, MD

  RMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Department of Gastroenterology

Study Record Dates

• First Submitted: December 25, 2008
• First Posted: December 29, 2008
• Study Start: October 1, 2009
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

IL (1)