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Key Adverse Events After Childhood Cancer

Primary Investigator
Jasty-Rao, Rama
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT00082745
UM Number
COG ALTE03N1
Age Group
Both
Management Group
CTSU - Oncology
Oncology Group
Childhood Cancers
ID (Protocol)
6896
Secondary Protocol No
HUM00040931
Scope
Unspecified
Sponsor Type
Institutional
Disease Site
Unknown Sites
Summary
This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, avascular necrosis, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Eligibility: Inclusion Criteria
  •   Ages Eligible for Study: up to 21 Years (Child, Adult)
  •   Genders Eligible for Study: Both
  •   Accepts Healthy Volunteers: No
  •   Sampling Method: Non-Probability Sample
  •   Patients with a diagnosis of primary cancer at age 21 or younger meeting other criteria
  •   ELIGIBILITY CRITERIA - CASES
  •   Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  •   No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  •   Development of one of the following key adverse events at any time following initiation of cancer therapy:
    •   Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual
    •   Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual
  •   Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Childrens Research Hospital as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patients white blood cell (WBC) is > 2,000
  •   Written informed consent from the patient and/or the patients legally authorized guardian
  •   In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
  •   ELIGIBILITY CRITERIA - CONTROLS
  •   CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  •   CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  •   CONTROLS: No clinical evidence of any of the following key adverse events:
    •   Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patients WBC is > 2,000
    •   Myocardial infarction (MI)
    •   Ischemic stroke (IS)
    •   Avascular necrosis (AVN)
    •   Subsequent malignant neoplasm (SMN)
  •   CONTROLS: Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Childrens Research Hospital as per the requirements
  •   CONTROLS: Written informed consent from the patient and/or the patients legally authorized guardian
  •   CONTROLS: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required