Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

Official Title

Key Adverse Events After Childhood Cancer

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.

Trial Description

Primary Outcome:

• Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)
• Frequency of mutations or polymorphisms in specific candidate genes in cases and controls
• Crude disease-exposure

Primary Objectives:

• 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 the therapeutic protocol.
• To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.
• To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls.
• To explore the role and nature of gene-environment interaction in the development of key adverse events.

Outline: DNA and RNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.

View this trial on ClinicalTrials.gov