Screening for Gastric Cancer in High-risk Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Characterization of the high-rik individual for gastric cancer - "Gastric Cancer Phenotype"
研究概览
简要总结
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:
- 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.
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.
详细描述
High Risk Population
First degree relatives of patients with gastric cancer have a 1.5-fold to 3-fold increased risk of developing gastric cancer themselves (Brenner H et al, Cancer 2000;88:274-9). In relatives of gastric cancer patients who are also carriers of a CagA positive strain of H. pylori, the risk is 8-fold. Mucosal atrophy, hypochlorhydria, high lymphoid follicle density, pangastritis, and interleukin 1 β polymorphism are frequent in family members of gastric cancer patients and are associated with increased risk of the disease (El-Omar EM et al, Gastroenterology 2000;118:22-30, Sepulveda A et al, Am J Gastroenterol 2002;97:1365-70).
Helicobacter Pylori - Carcinogen Number I
Helicobacter pylori is the main known carcinogen. The positive correlation between H. pylori infection and development of gastric cancer is well established and proved in prospective, controlled, studies, in Japan (Uemura N et al, N Engl J Med 2001;345:784-9, Fukase K et al, JAMA 2008;372:392-7).
Genetic changes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First relative, man or woman, of gastric cancer patients.
- •Signed informed consent.
排除标准
- •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.
结局指标
主要结局
Characterization of the high-rik individual for gastric cancer - "Gastric Cancer Phenotype"
时间窗: 2 years
次要结局
- Establish a screen plan for high-risk population for gastric cancer(2 years)
研究者
Yaron Niv
Director Department of Gastroenterology
Rabin Medical Center