Purpose

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.

Category

IRB Number
20090478HU
NCT Number
NCT00736749
Sponsor
Children's Oncology Group -



Study Contact

Principal Investigator
Shafqat Shah

Virginia Diaz
210-562-9149
diazvr@uthscsa.edu

Jaclyn Hung
210-450-5358
hungj@uthscsa.edu



Eligibility

Eligible Ages
Between N/A and N/A
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    • The patient must be enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy;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

        • CCG 5942
        • POG 9425
        • POG 9426
        • AHOD0031
        • AHOD1331
        • S1826 (COG patients only)

      • Brain tumor

        • A9961

      • Acute lymphoblastic leukemia

        • POG 9404

      • Osteosarcoma

        • POG 9754

      • Stem cell transplantation

        • ASCT0631D

      • Rhabdomyosarcoma

        • IRS-III
        • IRS-IV

      • Late Effects Protocols with Patients Eligible for Enrollment on ALTE05N1

        • ALTE15N1
        • ALTE16C1
      • Enrollment on ALTE05N1 must occur within 24 calendar months of the date the patient was enrolled on a frontline COG therapeutic trial; or patients previously enrolled on a COG (or Legacy Group) trial targeted for long term follow-up by ALTE05N1 may enroll on ALTE05N1 at any time
    • 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

Exclusion Criteria

    >

Study Design

Study Type
Observational
Condition
  • Acute Lymphoblastic Leukemia
  • Brain Neoplasm
  • Hematopoietic Cell Transplantation Recipient
  • Hodgkin Lymphoma
  • Osteosarcoma
  • Rhabdomyosarcoma

    • Arm Groups

    ArmDescriptionIntervention

    Observational (long-term follow-up)

    		Within 3 months of enrollment of ALTE05N1, patients receive a mailed packet introducing the LTFC. Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. 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 may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.
  • Other: Questionnaire Administration

    Complete patient response form and Health Status Update Form

  • Procedure: Assessment of Therapy Complications

    Complete patient response form and Health Status Update Form

    •