Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA

This study has been completed.
Sponsor:
Collaborators:
Children's Oncology Group
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588289
First received: December 24, 2007
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition
Pediatric Cancers
Oncology

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: CCG-LTFI: A Groupwide Protocol for Collecting Follow- up Data

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 102
Study Start Date: September 1999
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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

The patient must have completed anti-cancer treatment according to a CCG protocol, or must have been declared off protocol therapy, but not off study.

Criteria

Inclusion Criteria:

  • The patient must have completed anti-cancer treatment according to a CCG protocol, or must have been declared off protocol therapy, but not off study.
  • The data to be collected on the patient must include only those data that are documented in the medical record or included on the follow-up forms.

Exclusion Criteria:

  • n/a
  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: NCT00588289

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Children's Oncology Group
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Peter Steinherz, MD Memorial Sloan-Kettering Cancer Center
Study Chair: Joseph Neglia, MD, MPH University of Minnesota Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588289     History of Changes
Other Study ID Numbers: 99-068, CA42764
Study First Received: December 24, 2007
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Pediatric Cancers
Oncology

ClinicalTrials.gov processed this record on October 23, 2014