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Umbrella Long-Term Follow-Up Protocol


Primary Investigator
Mody, Rajen
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT00736749
UM Number
2018.148
Age Group
Both
Management Group
CTSU - Oncology
Oncology Group
Childhood Cancers
ID (Protocol)
15388
Secondary Protocol No
HUM00030599
Scope
Unspecified
Sponsor Type
Institutional

Disease Site
Hodgkin's Lymphoma
Leukemia, other
Liver
Lymphoid Leukemia
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Ovary
Pancreas
Rectum
Soft Tissue

Summary
This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

Eligibility: Inclusion Criteria
  •   Ages Eligible for Study: Child, Adult, Senior
  •   Genders Eligible for Study: Both
  •   Accepts Healthy Volunteers: No
  •   Sampling Method: Non-Probability Sample
  •   Patients with Hodgkin lymphoma enrolled on CCG-5942, POG-9425, POG-9426, COG-AHOD0031; patients with brain tumors enrolled on CCG-A9961; patients with acute lymphoblastic leukemia enrolled on POG-9404; patients with rhabdomyosarcoma
  •   The patient must be enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy and is nearing completion of or has recently completed protocol treatment (within the past 180 days)*; or the patient must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial targeted for long-term follow-up by ALTE05N1
    •   Hodgkin lymphoma: a.CCG-5942; b.POG-9425; c.POG-9426; d.COG-AHOD0031;
    •   Brain tumor: a.CCG-A9961;
    •   Acute lymphoblastic leukemia: a.POG-9404;
    •   Rhabdomyosarcoma:a. IRS-III; b.IRS-IV;
    •   Note: For purposes of enrollment onto this study, completion of treatment is defined as the date protocol therapy was terminated as reported (or will be reported) on this patients last "Reporting Period Worksheet/CRF" for their frontline therapeutic protocol; patients become eligible as they approach this date, and remain eligible for 180 days following the date that protocol therapy was terminated; early termination of protocol therapy per the decision of the patient, family and/or investigator does NOT preclude enrollment on this study
    •   Note: For purposes of eligibility for ALTE05N1, "early termination of protocol therapy" means that the patient has finished protocol therapy and will not receive further treatment; patients whose therapy is terminated early due to toxicity or who opt out of an end-of-therapy randomization (e.g., randomization to continue with an experimental agent vs. no further treatment) are eligible because they will not be receiving further therapy; however, a patient who is removed from protocol therapy or opts to discontinue protocol participation early in the course of treatment (e.g., following Induction) is not eligible
  •   The patient must reside in the U.S. on the date of enrollment to ALTE05N1
  •   All patients and/or their parents or legal guardians must sign a written informed consent
  •   All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met