Constitution d'Une Cohorte Nationale rétrospective de Survivants d'un Cancer Solide de l'Enfant diagnostiqué Avant 2000
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18,000
- 试验地点
- 66
- 主要终点
- All health events of interest
研究概览
简要总结
The FCCSS is a multicentric national large-scale collaborative population-based study of children treated for a solid tumor before 2000 in France and before the age of 19 years.
The study is concerned by improving knowledge about the long-term effects caused by cancer and its treatments including adverse health and social outcomes.
The main reason of the FCCSS is to estimate the risk of adverse health and social outcomes that may occur after a cancer treatment and to prevent them by providing adapted follow-up care.
The cohort will be followed for up to 20 years from 2011.
详细描述
The main objectives of the FCCSS are to:
- estimate the relationship between doses received (radiotherapy, chemotherapy) at a given organ and risk of second malignancy tumors;
- help identify patients at higher risk;
- compare the mortality occurred among the survivors with the general population;
- investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (such as cardiovascular, cerebrovascular and thyroid diseases, diabetes,…);
- characterize survivors with respect to socioeconomic status and quality of life.
The cohort will be ascertained using:
- the medical records from the treatment centers in order to characterize the childhood cancer, estimate doses of radiotherapy received by all organs and measure the chemotherapy administered;
- the French National Identification Registry and the French Death Registry in order to obtain the vital status and the causes of the deaths for the former patients
- a self-questionnaire that covers the entire future of the survivors (e.g. social status, family network, fertile offspring, access to care, access to bank loans, occupation,...);
- the French National Health Insurance Information System that contains data on all reimbursements for health expenditure including medicinal products as well as outpatient medical and nursing care, prescribed or performed by healthcare professionals.
In an initial cohort, we have already studied the iatrogenic effects of the cancer treatments. We have estimated the doses of ionising radiations delivered by radiotherapy to the target volume and by organs at distance. We found an important role of the radiotherapy and chemotherapy in the risk of a second cancer:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All types of solid childhood cancer in France
- •Age at diagnosis: Below age 19
- •Period of diagnosis: between 1st January 1942 and 31st December 1999
- •Complete identification (first name, last name, date of birth and place of birth)
排除标准
- •Leukaemia cases
结局指标
主要结局
All health events of interest
时间窗: by time since diagnosis of solid childhood cancer
* all causes mortality (e.g. cerebrovascular, cardiovascular,...) * all iatrogenic events (e.g. diabetes, thyroid adenomas, cardiac diseases, second malignant solid tumors, secondary leukemia,...)
次要结局
未报告次要终点