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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 18, 2014
Last verified: June 2014
  Purpose

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.
  • 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, the standard measure of cardiac function utilized in current screening strategies

Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of a Lifetime of Cohort of Adults Surviving Childhood Cancer

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ]

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.


Estimated Enrollment: 5200
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)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760656

Contacts
Contact: Melissa Hudson, MD 1-866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Melissa M Hudson, MD    866-278-5833    info@stjude.org   
Principal Investigator: Melissa M Hudson, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
American Society of Clinical Oncology
Rally Foundation
Memorial Sloan-Kettering Cancer Center
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Melissa Hudson, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided by St. Jude Children's Research Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00760656     History of Changes
Other Study ID Numbers: SJLIFE, R01CA157838
Study First Received: September 25, 2008
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Health outcomes in adults who survived pediatric cancer
Survivors of Pediatric Cancer

ClinicalTrials.gov processed this record on September 18, 2014