LIFE Cancer Survivorship Database for Pediatric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Children's Hospital Los Angeles
Sponsor:
Collaborator:
Beckman Research Institute
Information provided by (Responsible Party):
David Freyer, DO, MS, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01518400
First received: January 11, 2012
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to develop a mechanism for utilizing the comprehensive clinical database of childhood cancer survivors at Childrens Hospital Los Angeles (CHLA) for research purposes. Using clinical information obtained from follow-up visits of childhood cancer survivors, the database will focus on interventions to improve health status and health-related quality of life in childhood cancer survivors. This study allows for establishment and analyses of a research database for LIFE survivors by the investigators listed herein. Over the last three decades, there has been marked improvement in survival following childhood cancer, with 5-year survival rates now approaching 80%. However, the use of cancer therapy at an early age can result in complications that may not be apparent until years later as the child matures. These resulting complications, called late effects, are principally related to the specific therapy employed and the age of the child at the time the therapy was administered. Late effects may affect virtually every body system and substantially impair quality of life. As many as two-thirds of childhood cancer survivors develop at least one late effect as a result of treatment, and approximately one-third have a late effect classified as severe or life threatening.


Condition
Pediatric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Research Database for Survivors of Childhood Cancer

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • create a database of Cancer Survivors [ Time Frame: Annual (up to 40 years) ] [ Designated as safety issue: No ]
    To use the information gained from this assessment for identification of risk factors and populations at risk, and to develop interventions to improve health status and quality of life (QOL) in childhood cancer survivors.


Estimated Enrollment: 5000
Study Start Date: February 2009
Estimated Study Completion Date: December 2050
Estimated Primary Completion Date: January 2050 (Final data collection date for primary outcome measure)
Groups/Cohorts
Eligible Population
Cancer Survivors of all ages (Must be diagnosed with cancer at 21 years or younger)

Detailed Description:

Eligibility Criteria: Eligibility criteria include (1) a history of cancer or similar illness diagnosed before 22 years of age; (2) cancer in remission. Methods: For subjects enrolled on this study, clinical data will be entered into the LIFE database as routinely done for all survivors, but tagged so that research analyses may be carried out and limited only to those who are enrolled on this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Population diagnosed with cancer at 21 years of age or younger

Criteria

Inclusion Criteria:

  1. Been diagnosed with cancer or similar disease
  2. Been diagnosed with cancer at 21 years of age or younger
  3. Be currently off treatment and disease free
  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: NCT01518400

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leah Reichman, MPH    323-361-5973    lreichman@chla.usc.edu   
Principal Investigator: David Freyer, DO, MS         
Sponsors and Collaborators
Children's Hospital Los Angeles
Beckman Research Institute
Investigators
Principal Investigator: David Freyer, DO Children's Hospital Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: David Freyer, DO, MS, Director, LIFE Cancer Survivorship and Transition Program, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01518400     History of Changes
Other Study ID Numbers: CCI-09-00027
Study First Received: January 11, 2012
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Los Angeles:
Pediatric Cancer
Cancer Late Effects
Cancer Survivor
Cancer Survivorship

ClinicalTrials.gov processed this record on August 20, 2014