- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01518400
LIFE Cancer Survivorship Database for Pediatric Cancer
June 9, 2022 updated by: David Freyer, DO, MS, Children's Hospital Los Angeles
A Research Database for Survivors of Childhood Cancer
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.
Study Overview
Status
Recruiting
Conditions
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
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katie Villabroza
- Phone Number: 323-361-7203
- Email: kvillabroza@chla.usc.edu
Study Locations
-
-
California
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Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital Los Angeles
-
Contact:
- Katie Villabroza
- Phone Number: 323-361-7203
- Email: kvillabroza@chla.usc.edu
-
Principal Investigator:
- David Freyer, DO, MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Population diagnosed with cancer at 21 years of age or younger
Description
Inclusion Criteria:
- Been diagnosed with cancer or similar disease
- Been diagnosed with cancer at 21 years of age or younger
- Be currently off treatment and disease free
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Eligible Population
Cancer Survivors of all ages (Must be diagnosed with cancer at 21 years or younger)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Annual (up to 40 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Freyer, DO, MS, Children's Hospital Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Anticipated)
January 1, 2050
Study Completion (Anticipated)
December 1, 2050
Study Registration Dates
First Submitted
January 11, 2012
First Submitted That Met QC Criteria
January 25, 2012
First Posted (Estimate)
January 26, 2012
Study Record Updates
Last Update Posted (Actual)
June 13, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CCI-09-00027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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