Childhood Cancer Survivor Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50,000
- 试验地点
- 62
- 主要终点
- To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors.
研究概览
简要总结
The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer and its associated therapies. A retrospective cohort study will be conducted through a multi-institutional collaboration, which will involve the identification and active follow-up of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age, between 1970 and 1999 and 10,000 sibling controls. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.
详细描述
The study will focus on the following objectives:
- Characterize survivors' health with respect to disease- and treatment-related factors.
- Investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (e.g., cardiovascular, reproductive, second cancers, etc…).
- Compare the mortality experience of survivors with the general population.
- Characterize the health-related behaviors, patterns of medical care, and medical follow-up needs of survivors.
- Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes.
- Collect and store biologic samples (saliva, blood, second tumor tissue) to correlate with health outcomes and use for future research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Initial Cohort:
- •Five-year survival following diagnosis of leukemia, lymphoma, CNS tumor, bone tumor, Wilms tumor, neuroblastoma, or soft tissue sarcoma before age 21 years between January 1, 1970 and December 31, 1986 at one of participating centers.
- •Expanded cohort:
- •Five-year survival following diagnosis of leukemia, lymphoma, CNS tumor, bone tumor, kidney tumor, neuroblastoma, or rhabdomyosarcoma before age 21 years between January 1, 1987 and December 31, 1999 at one of participating centers.
- •English- or Spanish-speaking and living in the U.S. or Canada at the time of diagnosis.
排除标准
- •Diagnosis of non-malignant tumors (i.e., Langerhans cell histiocytosis, meningioma, craniopharyngioma, etc.) treated with radiation and/or chemotherapy.
- •Non-English speaking or residence outside the US or Canada.
- •Sibling Controls:
- •For comparison purposes, a group of sibling controls will be identified to represent a stratified random sample based on the distribution of survivors with regard to cancer diagnosis, age, sex, race, and geographic location.
研究组 & 干预措施
Sibling Controls
A group of sibling controls will be identified to provide: (1) the ability to make direct comparisons with the survivors, (2) data on outcomes in a non-cancer population, and (3) additional comparison group to determine consistency of findings between data sources.
Cancer survivors
Survivors of cancer, diagnosed under 21 years of age, between 1970 and 1999 This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, for an increased risk of late-occurring events associated with excess mortality and morbidity.
结局指标
主要结局
To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors.
时间窗: 25 years
次要结局
未报告次要终点