Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA
This protocol is not an independent research study, but rather a means to aggregate Children's Cancer Group protocols that are closed to patient entry for the purpose of collecting current status information on those patients treated under those protocols.
|Study Design:||Time Perspective: Prospective|
|Official Title:||CCG-LTFI: A Groupwide Protocol for Collecting Follow- up Data|
- Facilitate reporting of adverse events for those who completed treatment; To establish a mechanism for regular annual approval; Decrease the number of active protocols; Develop a framework for future studies of long-term health related outcomes. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 1999|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Children's Cancer Group clinical trials are conducted to improve understanding of the biology and treatment of childhood cancers. Protocols are developed by expert committees and distributed from the Group Operations Center to the member institutions. Before a protocol can be opened to patient accrual at a CCG institution, the protocol, consent form and any activation amendments are reviewed and approved by the local Institutional Review Board QRB).
Protocols remain open to patient accrual until sufficient evaluable patients have been entered to answer the study questions. During this time, the protocol and any new amendments are reviewed annually by the IRB. When the study has been closed to patient accrual it remains open solely for the purpose of collecting life status and occurrence of adverse events. The IRB must continue its annual review as long as a patient treated on the protocol is alive and follow-up data are being collected. The CCG Long Term Follow-up protocol (CCG-LTF1) is meant to allow continued collective review of all protocols that meet the following criteria: (a) It is closed to patient accrual, (b) all patients have completed treatment, and (c) there are patients who are alive and being followed. The protocols that meet these criteria will be listed as being aggregated under CCG-LTF1 such that an IRB review of CCG-LTF1 will constitute a review of that protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588289
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Peter Steinherz, MD||Memorial Sloan Kettering Cancer Center|
|Study Chair:||Joseph Neglia, MD, MPH||University of Minnesota Medical Center|