Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer (SJLIFE)
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ClinicalTrials.gov Identifier: NCT00760656 |
Recruitment Status :
Recruiting
First Posted : September 26, 2008
Last Update Posted : August 2, 2023
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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, 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.
Condition or disease |
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Cancer |
Study Type : | Observational |
Estimated Enrollment : | 8000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer |
Actual Study Start Date : | September 13, 2007 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
Group/Cohort |
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Research Participants
Participants with a diagnosis of childhood malignancy treated or followed at SJCRH
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Control Participants
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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- 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. [ Time Frame: Until the last participant withdraws, is taken off study, or dies (up until December 2025) up to 20 years ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Childhood cancer survivors treated at SJCRH recruited from selected diagnostic groups of almost 4000 adults surviving 10 or more years from their diagnosis of childhood cancer.
Adults who are non-first degree relatives or friends of St. Jude patients or former St. Jude patients will be invited to participate as a control in this study during the time of the child's St. Jude clinic visit. Controls will be recruited by, and should discuss their desire to participate with, a member of the St. Jude Life clinical and/or research staff. The individual will then be registered as a "Research Participant" by a member of the study team and informed consent will be obtained using the SJLIFE Banking Control consent document.
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:
- ≥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.
Exclusion Criteria:
- Patient or control subject refuses to participate at any level of study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760656
Contact: Melissa Hudson, MD | 1-866-278-5833 | referralinfo@stjude.org |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Melissa M Hudson, MD 866-278-5833 referralinfo@stjude.org | |
Principal Investigator: Melissa M Hudson, MD |
Principal Investigator: | Melissa Hudson, MD | St. Jude Children's Research Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00760656 |
Other Study ID Numbers: |
SJLIFE R01CA157838 ( U.S. NIH Grant/Contract ) R01CA036401 ( U.S. NIH Grant/Contract ) U01CA195547 ( U.S. NIH Grant/Contract ) R03CA199516 ( U.S. NIH Grant/Contract ) R21CA202210 ( U.S. NIH Grant/Contract ) R01CA216354 ( U.S. NIH Grant/Contract ) |
First Posted: | September 26, 2008 Key Record Dates |
Last Update Posted: | August 2, 2023 |
Last Verified: | August 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Health outcomes in adults who survived pediatric cancer Survivors of Pediatric Cancer |