An observational study in Chemotherapeutic Agent Toxicity, Sarcoma and Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by Children's Cancer and Leukaemia Group. Status unknown at 21 sites in 2 countries. Open to participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2013-08-12.
Sponsored by Children's Cancer and Leukaemia Group · Observational
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.
OBJECTIVES:
Primary
Secondary
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.
1,691 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 300 is above the median of 125 across 244 observational studies indexed under Sarcoma.
Browse Sarcoma studies →Children's Cancer and Leukaemia Group is the lead sponsor of 46 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Received ifosfamide before the age of 21 as part of treatment for cancer including, but not limited to, any of the following:
May have been treated on one of the following clinical trials:
SIOP-MMT-95
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
CYP3A5 genotype
Renal function and nephrotoxicity
Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity
Comparison of measured glomerular filtration rate (GFR) with the Cole model
This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Children's Cancer and Leukaemia Group