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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-09-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric Cancers Oncology

Keywords

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Pediatric Cancers Oncology

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Steinherz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Joseph Neglia, MD, MPH

Role: STUDY_CHAIR

University of Minnesota Medical Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CA42764

Identifier Type: -

Identifier Source: secondary_id

99-068