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| Tracking Information | |||||
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| First Received Date ICMJE | August 8, 2007 | ||||
| Last Updated Date | July 2, 2009 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00514345 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Comparison of measured glomerular filtration rate (GFR) with the Cole model [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Comparison of measured glomerular filtration rate (GFR) with the Cole model | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide | ||||
| Official Title ICMJE | CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | up to 20 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | Ireland, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00514345 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000560128, CCLG-PK-2007-02, EU-20743 | ||||
| Study Sponsor ICMJE | Children's Cancer and Leukaemia Group | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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