Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer (SJLIFE)

This study is currently recruiting participants.
Verified December 2013 by St. Jude Children's Research Hospital
Sponsor:
Collaborators:
American Society of Clinical Oncology
Rally Foundation
Memorial Sloan-Kettering Cancer Center
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00760656
First received: September 25, 2008
Last updated: December 19, 2013
Last verified: December 2013

September 25, 2008
December 19, 2013
April 2007
December 2025   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00760656 on ClinicalTrials.gov Archive Site
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Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer
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:

  • 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 adult volunteers for future SJLIFE research.
  • To collect health outcomes data on a community control population for comparison purposes.

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 entails 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 will include 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 20 groups of 20 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 survivors in the cross-sectional cohort will inform the final composition of the "high priority" cohort that will be invited to continue with periodic onsite evaluations in the prospective study. Evaluations will be undertaken using the same risk-based assessment as recommended by the COG Guidelines. The frequency of follow-up of the specific diagnostic subtypes will vary according to the prevalence of treatment complications determined during the cross-sectional study. In general, most survivors will have evaluations scheduled every 2 to 5 years. Survivors not targeted as high priority for onsite outcomes investigation will continue with follow-up through mail questionnaires and the St. Jude Cancer Registry.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

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.

Cancer
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5200
December 2025
December 2025   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient will have a diagnosis of childhood malignancy treated or followed at St. Jude Children's Research Hospital.
  • Patient will be a St. Jude alumnus at least ten years from diagnosis.
  • Patient is at least 18 years of age
  • 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 must sign informed consent for study participation.

Control Participant:

  • ≥18 years of age
  • Non-first degree 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.
  • Participant will have no medical history of cancer.
  • 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.

Cardiopulmonary Function Testing Inclusion Criteria:

  • Patient is a SJLIFE participant.
  • Patient does not have a history of congenital heart disease.
  • Patient is not pregnant.
  • Patient is at least three months postpartum.
  • Patient is at risk for a cardiopulmonary late effect according to COG Long-Term Follow-up Guidelines or patient is selected as a survivor control for comparison to those exposed to cardiotoxic agents.

Exclusion Criteria:

  • Patient refuses to participate at any level of study
Both
18 Years and older
No
Contact: Melissa Hudson, MD 1-866-278-5833 info@stjude.org
United States
 
NCT00760656
SJLIFE, R01CA157838
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
  • National Cancer Institute (NCI)
  • American Society of Clinical Oncology
  • Rally Foundation
  • Memorial Sloan-Kettering Cancer Center
  • University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Melissa Hudson, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP