NCT00760656 Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer
| NCT ID | NCT00760656 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2007-09-13 |
| Primary Completion | 2035-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 10,000 participants in total. It began in 2007-09-13 with a primary completion date of 2035-12-31.
⚠ 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
Childhood cancer predisposes to health risks that may not become apparent until many years after completion of therapy. The SJLIFE protocol is designed to establish a lifetime cohort of childhood cancer survivors treated at St. Jude Children's Research Hospital to facilitate evaluation of health outcomes in aging adults surviving pediatric cancer. The study focuses on the following Primary and secondary objectives: * To establish a lifetime cohort of childhood cancer survivors treated at St. Jude Children's Research Hospital to facilitate evaluation of health outcomes in aging children and adults surviving pediatric cancer. * To estimate the prevalence, cumulative incidence, and latency of selected late treatment complications following predisposing therapeutic exposures in children and adults surviving pediatric cancer. * To identify treatment, demographic, and psychosocial / behavioral related predictors of adverse health outcomes. * To develop risk profiles for adverse health outcomes across the age spectrum to guide development of clinical screening guidelines and risk-reducing interventions. * To identify factors that may be protective against the development of specific late treatment complications. * To generate data for a series of future hypothesis-driven trials * To serve as a source for the collection of samples from child and adult volunteers for future SJLIFE research. * To collect health outcomes data on a community control population for comparison purposes. * Characterize longitudinal social determinants of health (SDOH) to examine how living conditions, social integration, and structural inequality interact with personal social integrations/support to influence health.
Eligibility Criteria
Survivor Inclusion Criteria: * Patient will have a diagnosis of childhood malignancy (or neoplasm requiring similar therapy) that was treated or followed at St. Jude Children's Research Hospital. * Patient will be at least five years from diagnosis. * Patient is willing to participate at any level of study * Patient is willing to comply with the guidelines of St. Jude domiciliary care facilities * Patient or legally authorized representative must sign informed consent for study participation. Control Participant Inclusion Criteria: * ≥5 years of age * Non-first degree relatives or friends of St. Jude patients or former patients or SJCRH employees/affiliates who are not SJLIFE study team members, or family members of SJLIFE study team, or supervised by a SJLIFE study team members, or any volunteer not associated with St. Jude. * Participant does not have a diagnosis of childhood malignancy or childhood neoplasm requiring similar therapy (i.e., diagnosed \<21 years of age). * Participant is not currently pregnant or lactating. * Patient is willing to comply with the guidelines of St. Jude domiciliary care facilities. * Patient must sign informed consent for study participation. Gait and Mobility Lab Assessment Inclusion Criteria: * Enrolled participant in the SJLIFE study. * At-risk for long lasting difficulties with walking or other aspects of mobility. * Participant is not currently pregnant. * Participant or their designee signs informed consent for Gait and Mobility Lab Assessment participation. Survivor/Control Exclusion Criteria: * Patient or control subject refuses to participate at any level of study Gait and Mobility Lab Assessment Exclusion Criteria: * Prospective participant or their designee declines participation in the Gait and Mobility Lab Assessment.
Contact & Investigator
Melissa Hudson, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT00760656 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, 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 NCT00760656 currently recruiting?
Yes, NCT00760656 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT00760656 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT00760656 clinical trial?
NCT00760656 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Melissa Hudson, MD at St. Jude Children's Research Hospital. The trial plans to enroll 10,000 participants.
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