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Childhood Cancer Survivor Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01120353
Recruitment Status : Recruiting
First Posted : May 10, 2010
Last Update Posted : December 6, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Nationwide Children's Hospital
M.D. Anderson Cancer Center
University of Southern California
Children's Hospital Medical Center, Cincinnati
University of California, San Francisco
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Description
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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.

Condition or disease
Cancer

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Childhood Cancer Survivor Study
Actual Study Start Date : January 5, 1995
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. [ Time Frame: 25 years ]

Biospecimen Retention:   Samples With DNA
Blood, saliva and second tumor specimens

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed with cancer between January 1, 1970 and December 31, 1999 at one of the participating centers noted below or identified as sibling control.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120353


Contacts
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Contact: Gregory T. Armstrong, MD, MSCE 1-866-278-5833 referralinfo@stjude.org

Locations
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Sponsors and Collaborators
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Nationwide Children's Hospital
M.D. Anderson Cancer Center
University of Southern California
Children's Hospital Medical Center, Cincinnati
University of California, San Francisco
Investigators
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Principal Investigator: Gregory T. Armstrong, MD, MSCE St. Jude Children's Research Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01120353    
Other Study ID Numbers: CCSS
U24CA055727 ( U.S. NIH Grant/Contract )
R03CA169150 ( U.S. NIH Grant/Contract )
R01CA134722 ( U.S. NIH Grant/Contract )
R01CA136783 ( U.S. NIH Grant/Contract )
R01CA132899 ( U.S. NIH Grant/Contract )
R01CA187397 ( U.S. NIH Grant/Contract )
R01CA175231 ( U.S. NIH Grant/Contract )
R21CA202210 ( U.S. NIH Grant/Contract )
R21CA198641 ( U.S. NIH Grant/Contract )
NCI-2021-05717 ( Registry Identifier: NCI )
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
Childhood cancer
Young Children
Adults