Childhood Cancer Survivor Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Childhood Cancer Survivor Study

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer survivors<br>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. | |
| Sibling Controls<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. |  | 25 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood cancer, Young Children, Adults