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Clinical Trials (PDQ®)

Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyActive30 and underNCI, OtherALTE05N1
NCI-2009-00382, CDR0000590123, U10CA098543, COG-ALTE05N1, NCT00736749

Trial Description

Summary

This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.

Further Study Information

OBJECTIVES:

I. To develop a mechanism for tracking and retaining patients enrolled on COG protocols.

II. To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported health status.

III. To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC).

IV. To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution.

V. To facilitate collection of protocol-specific outcome data through collaboration with the COG Late Effects Committee, the SDC, and the member institutions.

VI. To collect cumulative therapeutic exposure data (via therapeutic summaries completed online by treating institutions) on patients completing active therapy.

OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions.

Approximately 6 months after completion of therapy patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC) and containing information related to their individualized, protocol-specific follow-up guidelines. Patients are asked to complete a patient response form, verify information provided in packet, update contact information, and complete a Health Status Update Form. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients receive protocol-specific automatic reminders, and may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone.

Eligibility Criteria

Inclusion Criteria:

  • Must be newly diagnosed with a primary malignancy and enrolled on a front line COG therapeutic trial for treatment of a primary malignancy OR must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial calling for long-term follow-up, including any of the following:
  • Hodgkin lymphoma
  • CCG-5942
  • POG-9425
  • POG-9426
  • COG-AHOD0031
  • Brain tumor
  • CCG-A9961
  • Acute lymphoblastic leukemia
  • COG-ALTE02C2
  • Neuroblastoma
  • COG-A3973
  • Rhabdomyosarcoma
  • IRS-III
  • IRS-IV-Stage 1
  • IRS-IV-Stage 2/3
  • IRS-IV-Stage/Group 4
  • Must reside in the U.S. during trial enrollment

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Smita BhatiaPrincipal Investigator

Trial Sites

U.S.A.
New Jersey
  New Brunswick
 Saint Peter's University Hospital
 Stanley Calderwood Ph: 732-745-8600ext6163
  Email: kcovert@saintpetersuh.com

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00736749
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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