Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer (SJLIFE)
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 adults surviving pediatric cancer.
- To estimate the prevalence, cumulative incidence, and latency of selected late treatment complications following predisposing therapeutic exposures in adults surviving pediatric cancer.
- To identify treatment, genetic, 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.
- Additional Cardiopulmonary Function Testing aims: 1) Determine longitudinal change in cardiac function, in an aging population of adult survivors of childhood cancer, exposed to anthracycline chemotherapy and/or cardiac-directed RT, previously assessed 10 years ago (n=170), and currently at a mean of 20 years from diagnosis, and 29 years of age. 2) Identify whether myocardial strain provides early detection of functional cardiotoxicity (exercise capacity measured as maximum VO2) compared to ejection fraction in adults, the standard measure of cardiac function utilized in current screening strategies
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer|
- 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. [ Time Frame: Until the last participant withdraws, is taken off study, or dies (up until December 2025) up to 20 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Control Participants - Storage of Biological Specimens
Blood, serum and urine:
A peripheral blood order will be placed in MILLI by a member of the clinical staff and the control participant will have 23cc of peripheral blood (6cc each in 3 NaHeparin tube, 5cc in red top) collected for the study. The collected peripheral blood sample will be stored in the institutional tissue bank. The sample will be tagged accordingly and will be only released to fulfill future objectives of the SJLIFE protocol.
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||December 2025|
|Estimated Primary Completion Date:||December 2025 (Final data collection date for primary outcome measure)|
Participants with a diagnosis of childhood malignancy treated or followed at SJCRH
Siblings, parents, relatives or friends of St. Jude patients or former patients or SJCRH employees who are not SJLIFE study team members or supervised by a SJLIFE study team members
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00760656
|Contact: Melissa Hudson, MDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Melissa M Hudson, MD 866-278-5833 email@example.com|
|Principal Investigator: Melissa M Hudson, MD|
|Principal Investigator:||Melissa Hudson, MD||St. Jude Children's Research Hospital|