Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer (SJLIFE)
|First Received Date ICMJE||September 25, 2008|
|Last Updated Date||October 12, 2016|
|Start Date ICMJE||April 2007|
|Estimated Primary Completion Date||December 2025 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE
||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: 12/31/2020 ]|
|Change History||Complete list of historical versions of study NCT00760656 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer|
|Official Title ICMJE||Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer|
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:
SJLIFE will be implemented in progressive stages with specific objectives to permit knowledge gained in each phase to inform content/format/study design of subsequent stages. The planned stages of the study include 1) Pre-Recruitment Study, 2) Barriers to Participation Survey, 3) Pilot Study of Recruitment Strategies, 4) Pilot Studies of High-Risk Survivor Cohorts, 5) Cross-Sectional Study of 10-year survivors, and 6) Prospective Lifetime Cohort Study.
Stage I entailed telephone interviews with a random sampling of potentially eligible survivors to obtain subjective feedback regarding barriers and facilitators to SJLIFE recruitment and participation. The random sample included thirty alumnus survivors representing a broad representation of race, gender, attained age, years from diagnosis and primary diagnostic groups. The interview content comprised assessment of interest, decision-making factors, and barriers to participation, current
In Stage 2, the Barriers to Participation Survey will be distributed to a random sampling of 500 patients representative of the potentially eligible cohort by age, race, sex, geographic distribution, primary diagnosis and time from diagnosis; 200 patients will be randomly selected up front to receive follow-up communication by telephone if they fail to return completed surveys. Information obtained from responses to the questionnaire will inform a subsequent randomized recruitment trial and provide insight regarding retention procedures.
In Stage 3, a pilot study will be undertaken to assess feasibility and potential pitfalls in recruitment for the Lifetime Cohort. Introductory letters will be sent to 300 alumni survivors, with a broad representation across targeted diagnostic groups, to invite their participation in the Lifetime Cohort. Recruitment approaches will be informed by the findings of the Barriers to Participation Survey. Parameters that will be assessed related to feasibility include 1) accuracy of contact information in hospital system (need for tracing of potentially eligible research participants); 2) number of eligible participants actively or passively declining study participation; and 3) reasons for declining participation. The pilot study will provide insight regarding the need for implementing procedures to track potential study participants who are "lost to follow-up" or incentives to recruit and retain study participants.
In Stage 4, a pilot study will be undertaken in groups of survivors identified by SJLIFE investigators to be at high risk for cancer-related morbidity based on specific demographic, diagnostic, therapeutic, or genetic/familiar factors. In addition to utilizing data collected from the risk-based evaluations performed in the Cross-Sectional study these individuals will undergo more extensive assessment beyond the screening recommendations outlined in the COG Guidelines to determine the frequency and more thoroughly characterize the extent specific treatment complications, as well as define the need for further study. Knowledge gained in this pilot study will provide important preliminary results that will be used to develop proposals for extramural funding for further study of the identified vulnerable populations.
In Stage 5, a cross-sectional study of the cohort of 10 or more year alumnus survivors will be undertaken using a risk-based assessment as recommended by the COG Guidelines. The first year of the study will target accrual of survivors with a diagnosis of acute lymphoblastic leukemia, Hodgkin lymphoma, and acute myeloid leukemia who are 30 years or older. The second year will target enrollment of survivors of central nervous system tumors, Wilms' tumor and other bone/soft tissue sarcomas. The third year will target accrual of the remaining diagnostic subtypes. The prevalence of late treatment complications detected by risk-based screening will provide important information regarding the appropriateness of the COG Guidelines recommendations in at risk survivor populations after specific therapeutic exposures.
In Stage 6, information gained from the evaluations of 10-year survivors enrolled in the cohort provided compelling support for the potential benefits and knowledge to be gained by prospective and systematic evaluations of all cohort members. In addition, evaluation of participants earlier in survivorship (i.e., before 10 years from diagnosis) was perceived to enhance opportunities to characterize the pathophysiology of emerging late onset treatment-related toxicities. Therefore, the cohort will be expanded by changing the eligibility from +10 years of survival and +18 years of age to 5+ years from cancer diagnosis regardless of age. As part of the expansion of the SJLIFE study, participants will now undergo systematic organ function evaluations (e.g., echocardiography, pulmonary function testing, audiological testing, ophthalmologic evaluation, bone mineral density testing). In addition, all participants will undergo a comprehensive psychosocial assessment by a licensed social worker and receive, as needed, assistance with referrals to community providers and resources for ongoing care. In general, most survivors will have evaluations scheduled to occur within a 4 to 5 year interval.
Several activities are planned to optimize communication with participating survivors about research activities involving the Lifetime Cohort. A newsletter will be distributed on a semi-annual basis for the purpose of 1) maintaining contact through periodic mailings (which include an address correction request from the post-office that can identify individuals who have moved from their last known address and may require additional tracing to re-establish contact); 2) providing an update on the status of the project; and 3) maintaining and enhancing the relationship with participants and 4) educating survivors about selected topics of health-related importance. In addition, a website will be developed that will serve as a resource that updates the progress of Lifetime Cohort activities.
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. Employees who request to be in the study may volunteer if they are not a SJLIFE study team member or not supervised by a SJLIFE study team member.
As part of SJLIFE initiative a group of study subjects who are not survivors of childhood cancer (community controls) will be recruited. These controls will serve as a comparative group to the aging survivors in SJLIFE cohort for assessing health-related, psychosocial, and quality of life outcomes.
Control enrollment to this protocol is expected to average 200-300 participants in the first year; with an estimated targeted accrual of 1200.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|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.
|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.
|Intervention ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||8000|
|Estimated Completion Date||December 2025|
|Estimated Primary Completion Date||December 2025 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Cardiopulmonary Function Testing Inclusion Criteria:
|Ages||5 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00760656|
|Other Study ID Numbers ICMJE||SJLIFE
R01CA157838 ( US NIH Grant/Contract Award Number )
R01CA036401 ( US NIH Grant/Contract Award Number )
U01CA195547 ( US NIH Grant/Contract Award Number )
R03CA199516 ( US NIH Grant/Contract Award Number )
R21CA202210 ( US NIH Grant/Contract Award Number )
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||St. Jude Children's Research Hospital|
|Study Sponsor ICMJE||St. Jude Children's Research Hospital|
|Information Provided By||St. Jude Children's Research Hospital|
|Verification Date||October 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP