Childhood Cancer Survivor Study

Cancer Clinical Trial

Official title:

Childhood Cancer Survivor Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01120353
• Other study ID #: CCSS
• Secondary ID: U24CA055727R03CA
• Status: Recruiting
• Start date: January 5, 1995
• Est. completion date: November 2026

Study information

• Verified date: December 2023
• Source: St. Jude Children's Research Hospital
• Contact: Gregory T. Armstrong, MD, MSCE
• Phone: 1-866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	University of Michigan/Mott Children's Hospital	Ann Arbor	Michigan
United States	Emory University/Children's Health Care of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham/Children's of Alabama	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Ana & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Indiana University/Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of California-Los Angeles	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Children's Hospitals & Clinics of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Memorial-Sloan Kettering Cancer Center	New York	New York
United States	Children's Hospital of Orange County	Orange	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Louis Children's Hospital/The Washington University	Saint Louis	Missouri
United States	University of California-San Francisco	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Stanford University School of Medicine	Stanford	California
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (8)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Children's Hospital Medical Center, Cincinnati, Fred Hutchinson Cancer Center, M.D. Anderson Cancer Center, National Cancer Institute (NCI), Nationwide Children's Hospital, University of California, San Francisco, University of Southern California

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors.		25 years

External Links

•   Clinical Trials Open at St. Jude
•   Long-Term Follow-Up Study
•   St. Jude Children's Research Hospital