Screening for Familial Gastric Cancer in First Degree Relatives
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.
研究概览
简要总结
The purpose of this study is to determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in first degree relatives of individuals with familial gastric cancer.
详细描述
Rationale:
Familial gastric cancer (FGC) concerns about 10% of all gastric cancers. It has an impressive impact on both emotional and physical wellbeing of first degree relatives of patients with (early) onset of gastric cancer. FGC can in 1-3% be attributed to one single hereditary syndrome, the hereditary diffuse gastric cancer (HDGC). HDGC is associated with a CDH1 mutation in about 40 % of the cases. In case there is no CDH1 mutation, referred to as familiar diffuse gastric cancer (FDGC), it remains uncertain how to guide and/or screen family members. The same applies for the rare familial intestinal type gastric cancer (FIGC).
Aim:
In this study we want to determine the value of endoscopic screening in members of families with FGC, both FDGC and FIGC. Also, we will analyze the associations of life style factors, including dietary habits with the development of FDGC, to be able to built preventive strategies. Finally, we want to assess the psychological impact of our screening protocol.
Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (≥ 18 yrs), female and male relatives
- •fully legal competent (to simplify the common consent agreement for blood withdrawal, DNA analysis and serial endoscopies.)
- •individuals that signed the common consent agreement
- •first degree relative of an individual with diffuse gastric cancer from a FDGC-family, without proven mutation,
- •OR: 2 or more individuals with gastric carcinoma, at least one < 50 yrs
- •OR: 3 or more individuals with (diffuse/intestinal/other type) gastric carcinoma, any age
- •OR 1 individual with any type gastric carcinoma < 40 yrs
排除标准
- •immature individuals
- •actual gastric ulcer or gastric bleeding
- •previous diagnosis of gastric cancer
- •hypersensitivity to Indigocarmine
- •individuals with co-morbidity which might increase the sedation and/or endoscopy risk: COPD Gold III/IV Cardiac failure Increased bleeding tendency or use of medication which increases bleeding tendency
研究组 & 干预措施
Endoscopy without staining of the mucosa
Endoscopy with staining of the mucosa.
干预措施: Endoscopy with staining of the mucosa (Other)
结局指标
主要结局
The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.
时间窗: all patients will have a follow up of five years, during which four endoscopies will be performed
次要结局
- To determine the optimal pathological work-up the detection rate of (pre-)malignancy, measured by the number of (pre) malignant foci found by the pathologist with different coloring and immunohistochemic techniques.(all patients will have a follow up of five years, during which four endoscopies with biopsy sampling will be performed)
- To determine the psychosocial impact of the screening protocol in this population, measured as the amount of stress and anxiety by use of the Hospital Anxiety and Distress Scale and the amount of cancer-worry by use of the Cancer Worry Scale.(during the follow up period of five years, each patient will receive questionaires at six time points. Assessment of these data will be performed after finishing the follow-up of the last patient, about six years after the start of this study.)
- To determine the association of clinical and life style factors with the two type of Familial Gastric Cancer, partly assessed from the patients'clinical files (eg BMI), partly by assessment of possible risk factors in blood (eg Helicobacter Pylori).(after three years of follow up these data will be assessed)