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Childhood Cancer Survivor Study

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT01120353
Collaborator
National Cancer Institute (NCI) (NIH), Fred Hutchinson Cancer Center (Other), Nationwide Children's Hospital (Other), M.D. Anderson Cancer Center (Other), University of Southern California (Other), Children's Hospital Medical Center, Cincinnati (Other), University of California, San Francisco (Other)
50,000
Enrollment
31
Locations
381.9
Anticipated Duration (Months)
1612.9
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    50000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Childhood Cancer Survivor Study
    Actual Study Start Date :
    Jan 5, 1995
    Anticipated Primary Completion Date :
    Nov 1, 2026
    Anticipated Study Completion Date :
    Nov 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. [25 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham/Children's of Alabama Birmingham Alabama United States 35294
    2 City of Hope National Medical Center Duarte California United States 91010
    3 Children's Hospital Los Angeles Los Angeles California United States 90027
    4 University of California-Los Angeles Los Angeles California United States 90095
    5 Children's Hospital of Orange County Orange California United States 92868
    6 University of California-San Francisco San Francisco California United States 94143
    7 Stanford University School of Medicine Stanford California United States 94305
    8 Children's Hospital Colorado Aurora Colorado United States 80045
    9 Children's National Medical Center Washington District of Columbia United States 20010
    10 Emory University/Children's Health Care of Atlanta Atlanta Georgia United States 30322
    11 Ana & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60611-2605
    12 University of Chicago Chicago Illinois United States 60637
    13 Indiana University/Riley Hospital for Children Indianapolis Indiana United States 46202
    14 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    15 University of Michigan/Mott Children's Hospital Ann Arbor Michigan United States 48109
    16 Children's Hospitals & Clinics of Minnesota Minneapolis Minnesota United States 55404
    17 University of Minnesota Minneapolis Minnesota United States 55455
    18 Mayo Clinic Rochester Minnesota United States 55905
    19 St. Louis Children's Hospital/The Washington University Saint Louis Missouri United States 63130
    20 Roswell Park Cancer Institute Buffalo New York United States 14263
    21 Memorial-Sloan Kettering Cancer Center New York New York United States 10065
    22 Nationwide Children's Hospital Columbus Ohio United States 43205
    23 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    24 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    25 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    26 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    27 Cook Children's Medical Center Fort Worth Texas United States 76104
    28 M.D. Anderson Cancer Center Houston Texas United States 77030
    29 Texas Children's Hospital Houston Texas United States 77030
    30 Seattle Children's Hospital Seattle Washington United States 98105
    31 The Hospital for Sick Children Toronto Ontario Canada M5G-1XB

    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

    • Principal Investigator: Gregory T. Armstrong, MD, MSCE, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT01120353
    Other Study ID Numbers:
    • CCSS
    • U24CA055727
    • R03CA169150
    • R01CA134722
    • R01CA136783
    • R01CA132899
    • R01CA187397
    • R01CA175231
    • R21CA202210
    • R21CA198641
    First Posted:
    May 10, 2010
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    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

    Study Results

    No Results Posted as of Apr 29, 2022