Last updated on August 2013

CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide


Brief description of study

RATIONALE: Studying the genes expressed in samples of blood from young patients with cancer treated with ifosfamide may help doctors identify risk factors for kidney damage. PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a risk factor for kidney damage in young patients with cancer treated with ifosfamide.

Detailed Study Description

OBJECTIVES: Primary - To determine the CYP3A5 genotype in young patients with cancer who have received ifosfamide. - To document renal function and nephrotoxicity on one occasion between 1 month and 5 years after completion of ifosfamide treatment. - To determine the relationship between CYP3A5 genotype and ifosfamide nephrotoxicity. Secondary - To compare the measured glomerular filtration rate (GFR) (using a radioisotope clearance method) with that calculated using the Cole (weight and creatinine) model. OUTLINE: This is a multicenter study. Nephrotoxicity assessment is performed in patients who have not undergone prior assessment*. NOTE: *Nephrotoxicity assessment is performed once between 1 month and 5 years after completion of ifosfamide chemotherapy. All patients will undergo a single blood sample collection. DNA will be extracted from this sample and genotyped for the known functional polymorphisms in CYP3A5. The technique of restriction fragment length polymorphism (RFLP) will be used to detect any single nucleotide polymorphisms in CYP3A5. DNA may be obtained from stored tumor samples from patients for whom the results of renal investigations are available, but for whom blood is not available for CYP3A5 genotyping.

Clinical Study Identifier: NCT00514345

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