Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer (NCT00760656) | Clinical Trial Compass
RecruitingNot Applicable
Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer
United States10,000 participantsStarted 2007-09-13
Plain-language 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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 La…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Until the last participant withdraws, is taken off study, or dies (up until December 2025) up to 20 years