LIFE Cancer Survivorship Database for Pediatric Cancer

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. Identifier: NCT01518400
Recruitment Status : Recruiting
First Posted : January 26, 2012
Last Update Posted : February 6, 2017
Information provided by (Responsible Party):
David Freyer, DO, MS, Children's Hospital Los Angeles

Brief Summary:
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 or disease
Pediatric Cancer

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.

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Research Database for Survivors of Childhood Cancer
Study Start Date : February 2009
Estimated Primary Completion Date : January 2050
Estimated Study Completion Date : December 2050

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Eligible Population
Cancer Survivors of all ages (Must be diagnosed with cancer at 21 years or younger)

Primary Outcome Measures :
  1. create a database of Cancer Survivors [ Time Frame: Annual (up to 40 years) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population diagnosed with cancer at 21 years of age or younger

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

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 identifier (NCT number): NCT01518400

Contact: Diana Palma 323-361-5973

United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Diana Palma    323-361-5973   
Principal Investigator: David Freyer, DO, MS         
Sponsors and Collaborators
Children's Hospital Los Angeles
Principal Investigator: David Freyer, DO Children's Hospital Los Angeles

Responsible Party: David Freyer, DO, MS, Director, LIFE Cancer Survivorship and Transition Program, Children's Hospital Los Angeles Identifier: NCT01518400     History of Changes
Other Study ID Numbers: CCI-09-00027
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by David Freyer, DO, MS, Children's Hospital Los Angeles:
Pediatric Cancer
Cancer Late Effects
Cancer Survivor
Cancer Survivorship