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Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
Recruiting
I'm InterestedTrial ID: NCT00082745
Purpose
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.
Official Title
Key Adverse Events After Childhood Cancer
Stanford Investigator(s)
Eligibility
Inclusion 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
- 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 saliva specimen) to the
Coordinating Center at the University of Alabama at Birmingham 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
- 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
patient's WBC is > 2,000
- Ischemic stroke (IS)
- Avascular necrosis (AVN)
- Subsequent malignant neoplasm (SMN)
- CONTROLS: Submission of a blood specimen (or in certain cases a saliva specimen) to
the Coordinating Center Laboratory at the University of Alabama at Birmingham as per
the requirements
- CONTROLS: Written informed consent from the patient and/or the patient's 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
Intervention(s):
other: questionnaire administration
other: laboratory biomarker analysis
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jenny Joaquin
650-723-0618