Early Onset and Familial Gastric Cancer Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 971
- 试验地点
- 10
- 主要终点
- Create registry of families w/ early onset & familial gastric cancer for analysis of risk factors, family history and unidentified susceptibility genes. Create cohorts of pts w/ low genetic risk for the development of gastric cancer
研究概览
简要总结
The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers. As part of this study, you will be asked to join a registry of families who are affected with various forms of gastric cancer. These registries are important because they may help physicians better manage gastric cancer now and in the future. Participating in the Early Onset and Familial Gastric Cancer Registry can also be educational for families, since it will provide important information to patients, families, and physicians. All of this will help to further our understanding of genetic causes of gastric cancer and eventually, help determine better ways to diagnose, treat, and survey patients with gastric cancer and people who may have a higher risk for gastric cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient/Relative Cohort:
- •Must meet one or more criteria below:
- •A person with a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed at the treating institution.
- •A person without gastric or GEJ adenocarcinoma who has or had a first degree relative eligible for a High Risk Genetic sub-group (EOGC/FGC).
- •Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease.
- •Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives.
- •A person without gastric or GEJ adenocarcinoma who has a personal family history of a genetic mutation associated with the development of gastric or GEJ adenocarcinoma (i.e. family history of CDH1 mutation).
- •II. Must be willing to provide a blood sample for germline DNA. These individuals will sign the "Patient/Relative Consent". Following enrollment, we will assign individuals to the appropriate High Genetic Risk or Low Genetic Risk groups based on the age of diagnosis and their family history.
- •Subject Exclusion Criteria
- •Patients are ineligible for the study if they:
- •Have any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent.
- •Relatives of patients that are not eligible for the High Genetic Risk Cohorts who are less than 18 years of age are excluded.
- •Relatives of patients eligible for the High Genetic Risk Cohorts who do not have a proband available to join the study are excluded. (Unless there is a known CDH1 mutation in the family).
排除标准
- 未提供
结局指标
主要结局
Create registry of families w/ early onset & familial gastric cancer for analysis of risk factors, family history and unidentified susceptibility genes. Create cohorts of pts w/ low genetic risk for the development of gastric cancer
时间窗: December 2010
次要结局
- To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.(December 2010)
- To determine the gastric pathology evident from a single baseline endoscopic screen of unaffected first-degree relatives of a patient with EOGC or FGC.(December 2010)