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Clinical Trial COGALTE03N1


Key Adverse Events after Childhood Cancer

Principal Investigator(s)

Debra Friedman


  • Protocol No. COGALTE03N1
  • Open Date: 04/20/2005
  • Staging: N/A
  • Age Group: Children
  • Scope: National
  • Objective: To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of therapeutic protocol. To identify treatment-related and demograpahic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.
  • Disease Sites: Miscellaneous; Pediatrics
  • Therapies: Correlative
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT00082745
  • Secondary Protocol No: ALTE03N1


None Provided.


Ages Eligible for Study:N/A to 21 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• 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
• 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 WBC is > 2,000
• Written informed consent from the patient and/or the patient's legally authorized guardian, obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services
• 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