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CCG-LTFI: A Groupwide Protocol for Collecting Follow- up Data

Open (Enrolling)
Pediatric Cancers, Oncology

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Trial Information

CCG-LTFI: A Groupwide Protocol for Collecting Follow- up Data

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

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.

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

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Peter Steinherz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 1999

Completion Date:

December 2013

Related Keywords:

  • Pediatric Cancers
  • Oncology
  • Pediatric Cancers
  • Oncology



Memorial Sloan-Kettering Cancer Center New York, New York  10021