| NCT ID | NCT01120353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50,000 participants |
| Start Date | 1995-01-05 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50,000 participants in total. It began in 1995-01-05 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Gregory T. Armstrong, MD, MSCE
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT01120353 clinical trial?
This trial is open to participants of all sexes, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01120353 currently recruiting?
Yes, NCT01120353 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT01120353 trial being conducted?
This trial is being conducted at Birmingham, United States, Duarte, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT01120353 clinical trial?
NCT01120353 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Gregory T. Armstrong, MD, MSCE at St. Jude Children's Research Hospital. The trial plans to enroll 50,000 participants.
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