Umbrella Long-Term Follow-Up Protocol

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

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.

Who is eligible to participate?

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

Last updated:
2/5/2014
NCT ID:
NCT00736749
IRB Number:
09-006924