Clinical Trials (PDQ®)
|No phase specified||Natural history/Epidemiology||Active||30 and under||NCI, Other||ALTE05N1|
NCI-2009-00382, CDR0000590123, U10CA098543, COG-ALTE05N1, NCT00736749
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
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.
- 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
- Brain tumor
- Acute lymphoblastic leukemia
- IRS-IV-Stage 1
- IRS-IV-Stage 2/3
- IRS-IV-Stage/Group 4
- Must reside in the U.S. during trial enrollment
Trial Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
|Smita Bhatia||Principal Investigator|
|Saint Peter's University Hospital|
|Stanley Calderwood||Ph: 732-745-8600ext6163|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00736749
ClinicalTrials.gov processed this data on March 03, 2015
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