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

This study is currently recruiting participants.
Verified June 2017 by St. Jude Children's Research Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760656
First Posted: September 26, 2008
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
American Society of Clinical Oncology
Rally Foundation
Memorial Sloan Kettering Cancer Center
University of Minnesota - Clinical and Translational Science Institute
St. Baldrick's Foundation
American Institute for Cancer Research
American Cancer Society, Inc.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  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 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
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

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 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.


Estimated Enrollment: 8000
Actual Study Start Date: September 13, 2007
Estimated Study Completion Date: December 31, 2025
Estimated Primary Completion Date: December 31, 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

Information from the National Library of Medicine

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, Senior)
Sexes Eligible for Study:   All
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 (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 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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Melissa Hudson, MD 1-866-278-5833 referralinfo@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    referralinfo@stjude.org   
Principal Investigator: Melissa M Hudson, MD         
Sponsors and Collaborators
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
St. Baldrick's Foundation
American Institute for Cancer Research
American Cancer Society, Inc.
Investigators
Principal Investigator: Melissa Hudson, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
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 ( 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 Submitted: September 25, 2008
First Posted: September 26, 2008
Last Update Posted: June 12, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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