Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors (NCT00082745) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
United States3,885 participantsStarted 2004-03-25
Plain-language 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.
Who can participate
Age range99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 can…
What they're measuring
1
Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)
Timeframe: Up to 1 year
2
Frequency of mutations or polymorphisms in specific candidate genes in cases and controls