CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide
NCT ID: NCT00514345
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2007-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Interventions
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gene expression analysis
polymorphism analysis
management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* CCLG-EPSSG-RMS-2005
PATIENT CHARACTERISTICS:
* Clinically stable to undergo renal investigations
* No pre-existing renal impairment (glomerular or tubular) prior to treatment with ifosfamide
* No known nephrotoxicity for which nephrotoxic supportive treatment (aminoglycosides, amphotericin, acyclovir, cyclosporine, or tacrolimus) was a major contributory cause of renal damage
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from the acute non-renal toxicity of the last course of chemotherapy
* No other prior nephrotoxic chemotherapy (e.g., cisplatin, carboplatin, melphalan, or high-dose methotrexate)
* No prior radiotherapy to a field including the kidneys
* No prior removal of renal tissue
* No concurrent ifosfamide
20 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Gareth Veal
Role: PRINCIPAL_INVESTIGATOR
University of Newcastle Upon-Tyne
Locations
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Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
University College Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
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
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Martin W. English, MD
Role: primary
Contact Person
Role: primary
Amos Burke, MD
Role: primary
Adam Glaser, MD
Role: primary
Johann Visser, MD
Role: primary
Heather P. McDowell, MD
Role: primary
Maria Michelagnoli, MD
Role: primary
Gill Levitt, MD
Role: primary
Bernadette Brennan, MD
Role: primary
Juliet Hale, MD
Role: primary
Martin Hewitt, MD, BSc, FRCP, FRCPCH
Role: primary
Kate Wheeler, MD
Role: primary
Mary P. Gerrard, MBChB, FRCP, FRCPCH
Role: primary
Janice A. Kohler, MD, FRCP
Role: primary
Mary Taj, MD
Role: primary
Anthony McCarthy, MD
Role: primary
Veronica Neefjes
Role: primary
W. Hamish Wallace, MD
Role: primary
Milind D. Ronghe, MD
Role: primary
Heidi Traunecker, MD, PhD
Role: primary
Other Identifiers
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CDR0000560128
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20743
Identifier Type: -
Identifier Source: secondary_id
CCLG-PK-2007-02
Identifier Type: -
Identifier Source: org_study_id