Childhood Cancer Survivor Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Childhood Cancer Survivor Study|
- To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. [ Time Frame: 25 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood, saliva and second tumor specimens
|Study Start Date:||March 1994|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120353
|Contact: Gregory T. Armstrong, MD, MSCEfirstname.lastname@example.org|
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|Principal Investigator:||Gregory T. Armstrong, MD, MSCE||St. Jude Children's Research Hospital|