CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide
- Conditions
- Chemotherapeutic Agent ToxicitySarcomaUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00514345
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- Brief Summary
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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CYP3A5 genotype Renal function and nephrotoxicity Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity
- Secondary Outcome Measures
Name Time Method Comparison of measured glomerular filtration rate (GFR) with the Cole model
Trial Locations
- Locations (20)
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
🇬🇧Bristol, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
University College Hospital
🇬🇧London, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
🇬🇧Cardiff, Wales, United Kingdom
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
Royal Aberdeen Children's Hospital
🇬🇧Aberdeen, Scotland, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom