NCT00760656

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Sep 2007Dec 2035

Study Start

First participant enrolled

September 13, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
27.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

28.3 years

First QC Date

September 25, 2008

Last Update Submit

April 22, 2026

Conditions

Cancer

Keywords

Health outcomes in adults who survived pediatric cancerSurvivors of Pediatric Cancer

Outcome Measures

Primary Outcomes (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.

    Until the last participant withdraws, is taken off study, or dies (up until December 2025) up to 20 years

Study Arms (2)

Research Participants

Participants with a diagnosis of childhood malignancy treated or followed at SJCRH

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

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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. 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.

You may qualify if:

  • 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.
  • ≥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.
  • 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.

You may not qualify if:

  • Patient or control subject refuses to participate at any level of study
  • Prospective participant or their designee declines participation in the Gait and Mobility Lab Assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Publications (12)

  • Hammoud RA, Liu Q, Dixon SB, Onerup A, Mulrooney DA, Huang IC, Jefferies JL, Rhea IB, Ness KK, Ehrhardt MJ, Hudson MM, Ky B, Bhakta N, Sapkota Y, Yasui Y, Armstrong GT. The burden of cardiovascular disease and risk for subsequent major adverse cardiovascular events in survivors of childhood cancer: a prospective, longitudinal analysis from the St Jude Lifetime Cohort Study. Lancet Oncol. 2024 Jun;25(6):811-822. doi: 10.1016/S1470-2045(24)00157-8.

    PMID: 38821086DERIVED

  • Chang TC, Yu J, Wang Z, Hankins JS, Weiss MJ, Wu G, Westhoff CM, Chou ST, Zheng Y. Machine learning to optimize automated RH genotyping using whole-exome sequencing data. Blood Adv. 2024 Jun 11;8(11):2651-2659. doi: 10.1182/bloodadvances.2023011660.

    PMID: 38522094DERIVED

  • Lan T, Wang M, Ehrhardt MJ, Lanctot JQ, Jiang S, Armstrong GT, Ness KK, Hudson MM, Colditz GA, Robison LL, Park Y. Dietary patterns and their associations with sociodemographic and lifestyle factors in adult survivors of childhood cancer: a cross-sectional study. Am J Clin Nutr. 2024 Mar;119(3):639-648. doi: 10.1016/j.ajcnut.2024.01.012. Epub 2024 Jan 24.

    PMID: 38278365DERIVED

  • Petrykey K, Lippe S, Sultan S, Robaey P, Drouin S, Affret-Bertout L, Beaulieu P, St-Onge P, Baedke JL, Yasui Y, Hudson MM, Laverdiere C, Sinnett D, Krajinovic M. Genetic Factors and Long-term Treatment-Related Neurocognitive Deficits, Anxiety, and Depression in Childhood Leukemia Survivors: An Exome-Wide Association Study. Cancer Epidemiol Biomarkers Prev. 2024 Feb 6;33(2):234-243. doi: 10.1158/1055-9965.EPI-23-0634.

    PMID: 38051303DERIVED

  • Chen C, Qin N, Wang M, Dong Q, Tithi SS, Hui Y, Chen W, Wu G, Kennetz D, Edmonson MN, Rusch MC, Thrasher A, Easton J, Mulder HL, Song N, Plonski NM, Shelton K, Im C, Ehrhardt MJ, Nichols KE, Leisenring WM, Stratton KL, Howell R, Yasui Y, Bhatia S, Armstrong GT, Ness KK, Hudson MM, Zhang J, Wang H, Srivastava DK, Robison LL, Wang Z. Cancer germline predisposing variants and late mortality from subsequent malignant neoplasms among long-term childhood cancer survivors: a report from the St Jude Lifetime Cohort and the Childhood Cancer Survivor Study. Lancet Oncol. 2023 Oct;24(10):1147-1156. doi: 10.1016/S1470-2045(23)00403-5.

    PMID: 37797633DERIVED

  • Bhatt NS, Baassiri MJ, Liu W, Bhakta N, Chemaitilly W, Ehrhardt MJ, Inaba H, Krull K, Ness KK, Rubnitz JE, Srivastava D, Robison LL, Hudson MM, Mulrooney DA. Late outcomes in survivors of childhood acute myeloid leukemia: a report from the St. Jude Lifetime Cohort Study. Leukemia. 2021 Aug;35(8):2258-2273. doi: 10.1038/s41375-021-01134-3. Epub 2021 Jan 25.

    PMID: 33495497DERIVED

  • Howell CR, Bjornard KL, Ness KK, Alberts N, Armstrong GT, Bhakta N, Brinkman T, Caron E, Chemaitilly W, Green DM, Folse T, Huang IC, Jefferies JL, Kaste S, Krull KR, Lanctot JQ, Mulrooney DA, Neale G, Nichols KE, Sabin ND, Shelton K, Srivastava DK, Wang Z, Wilson C, Yasui Y, Zaidi A, Zhang J, Robison LL, Hudson MM, Ehrhardt MJ. Cohort Profile: The St. Jude Lifetime Cohort Study (SJLIFE) for paediatric cancer survivors. Int J Epidemiol. 2021 Mar 3;50(1):39-49. doi: 10.1093/ije/dyaa203. No abstract available.

    PMID: 33374007DERIVED

  • Maciaszek JL, Oak N, Chen W, Hamilton KV, McGee RB, Nuccio R, Mostafavi R, Hines-Dowell S, Harrison L, Taylor L, Gerhardt EL, Ouma A, Edmonson MN, Patel A, Nakitandwe J, Pappo AS, Azzato EM, Shurtleff SA, Ellison DW, Downing JR, Hudson MM, Robison LL, Santana V, Newman S, Zhang J, Wang Z, Wu G, Nichols KE, Kesserwan CA. Enrichment of heterozygous germline RECQL4 loss-of-function variants in pediatric osteosarcoma. Cold Spring Harb Mol Case Stud. 2019 Oct 23;5(5):a004218. doi: 10.1101/mcs.a004218. Print 2019 Oct.

    PMID: 31604778DERIVED

  • Mulrooney DA, Hyun G, Ness KK, Bhakta N, Pui CH, Ehrhardt MJ, Krull KR, Crom DB, Chemaitilly W, Srivastava DK, Relling MV, Jeha S, Green DM, Yasui Y, Robison LL, Hudson MM. The changing burden of long-term health outcomes in survivors of childhood acute lymphoblastic leukaemia: a retrospective analysis of the St Jude Lifetime Cohort Study. Lancet Haematol. 2019 Jun;6(6):e306-e316. doi: 10.1016/S2352-3026(19)30050-X. Epub 2019 May 8.

    PMID: 31078468DERIVED

  • Mulrooney DA, Armstrong GT, Huang S, Ness KK, Ehrhardt MJ, Joshi VM, Plana JC, Soliman EZ, Green DM, Srivastava D, Santucci A, Krasin MJ, Robison LL, Hudson MM. Cardiac Outcomes in Adult Survivors of Childhood Cancer Exposed to Cardiotoxic Therapy: A Cross-sectional Study. Ann Intern Med. 2016 Jan 19;164(2):93-101. doi: 10.7326/M15-0424. Epub 2016 Jan 5.

    PMID: 26747086DERIVED

  • Krull KR, Zhang N, Santucci A, Srivastava DK, Krasin MJ, Kun LE, Pui CH, Robison LL, Hudson MM, Armstrong GT. Long-term decline in intelligence among adult survivors of childhood acute lymphoblastic leukemia treated with cranial radiation. Blood. 2013 Jul 25;122(4):550-3. doi: 10.1182/blood-2013-03-487744. Epub 2013 Jun 6.

    PMID: 23744583DERIVED

  • Krull KR, Sabin ND, Reddick WE, Zhu L, Armstrong GT, Green DM, Arevalo AR, Krasin MJ, Srivastava DK, Robison LL, Hudson MM. Neurocognitive function and CNS integrity in adult survivors of childhood hodgkin lymphoma. J Clin Oncol. 2012 Oct 10;30(29):3618-24. doi: 10.1200/JCO.2012.42.6841. Epub 2012 Sep 4.

    PMID: 22949149DERIVED

Related Links

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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Melissa Hudson, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Hudson, MD

CONTACT

888-226-4343referralinfo@stjude.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

September 13, 2007

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(1)