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Childhood Cancer Survivor Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by St. Jude Children's Research Hospital
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
Nationwide Children's Hospital
M.D. Anderson Cancer Center
University of Southern California
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01120353
First received: May 6, 2010
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Childhood Cancer Survivor Study

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 50000
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)
Groups/Cohorts
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.

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.
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120353

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

  Show 30 Study Locations
Sponsors and Collaborators
St. Jude Children's Research Hospital
Fred Hutchinson Cancer Research Center
Nationwide Children's Hospital
M.D. Anderson Cancer Center
University of Southern California
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Gregory T. Armstrong, MD, MSCE St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided by St. Jude Children's Research Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01120353     History of Changes
Other Study ID Numbers: CCSS, U24CA055727, R03CA169150, R01CA134722, R01CA136783, R01CA132899, R01CA187397, R01CA175231
Study First Received: May 6, 2010
Last Updated: October 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Childhood cancer
Young Children
Adults

ClinicalTrials.gov processed this record on November 27, 2014