Clinical Trials

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;
  • Ischemic stroke (IS);
  • Subsequent malignant neoplasm (SMN);
  • 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 Children's 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 patient's white blood cell (WBC) is > 2,000.
• Written informed consent from the patient and/or the patient?s 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.
• CONTROL: No prior history of allogeneic (non-autologous) hematopoietic cell transplant. 
• CONTROL: 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 patient's WBC is > 2,000;
  • Myocardial infarction (MI);
  • Ischemic stroke (IS);
  • Avascular necrosis (AVN);
  • Subsequent malignant neoplasm (SMN). 
• CONTROL: Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements. 
• CONTROL: Written informed consent from the patient and/or the patient?s legally authorized guardian. 
• CONTROL: 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.