CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00514345|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 9, 2007
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment|
|Chemotherapeutic Agent Toxicity Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific||Genetic: gene expression analysis Genetic: polymorphism analysis Procedure: management of therapy complications|
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children|
|Study Start Date :||July 2007|
- CYP3A5 genotype
- Renal function and nephrotoxicity
- Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity
- Comparison of measured glomerular filtration rate (GFR) with the Cole model
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514345
|Our Lady's Hospital for Sick Children Crumlin||Recruiting|
|Dublin, Ireland, 12|
|Contact: Contact Person 353-1-409-6659|
|Birmingham Children's Hospital||Recruiting|
|Birmingham, England, United Kingdom, B4 6NH|
|Contact: Martin W. English, MD 44-121-333-8412 email@example.com|
|Bristol Royal Hospital for Children||Recruiting|
|Bristol, England, United Kingdom, BS2 8BJ|
|Contact: Contact Person 44-117-342-0205|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Contact: Amos Burke, MD 44-1223-348-151|
|Leeds Cancer Centre at St. James's University Hospital||Recruiting|
|Leeds, England, United Kingdom, LS9 7TF|
|Contact: Adam Glaser, MD 44-113-206-4984 firstname.lastname@example.org|
|Leicester Royal Infirmary||Recruiting|
|Leicester, England, United Kingdom, LE1 5WW|
|Contact: Johann Visser, MD 44-116-258-5309 email@example.com|
|Royal Liverpool Children's Hospital, Alder Hey||Recruiting|
|Liverpool, England, United Kingdom, L12 2AP|
|Contact: Heather P. McDowell, MD 44-151-293-3679|
|University College Hospital||Recruiting|
|London, England, United Kingdom, NW1 2PCE|
|Contact: Maria Michelagnoli, MD 44-20-7380-9064 firstname.lastname@example.org|
|Great Ormond Street Hospital for Children||Recruiting|
|London, England, United Kingdom, WC1N 3JH|
|Contact: Gill Levitt, MD 44-20-7405-9200 ext. 0073|
|Royal Manchester Children's Hospital||Recruiting|
|Manchester, England, United Kingdom, M27 4HA|
|Contact: Bernadette Brennan, MD 44-161-922-2227 email@example.com|
|Sir James Spence Institute of Child Health at Royal Victoria Infirmary||Recruiting|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Contact: Juliet Hale, MD 44-191-282-4101 firstname.lastname@example.org|
|Queen's Medical Centre||Recruiting|
|Nottingham, England, United Kingdom, NG7 2UH|
|Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 63394 email@example.com|
|Oxford Radcliffe Hospital||Recruiting|
|Oxford, England, United Kingdom, 0X3 9DU|
|Contact: Kate Wheeler, MD 44-186-522-1066|
|Children's Hospital - Sheffield||Recruiting|
|Sheffield, England, United Kingdom, S10 2TH|
|Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH 44-114-271-7366 firstname.lastname@example.org|
|Southampton General Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942|
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Mary Taj, MD 44-20-8642-6011 ext. 3089|
|Royal Belfast Hospital for Sick Children||Recruiting|
|Belfast, Northern Ireland, United Kingdom, BT12 6BE|
|Contact: Anthony McCarthy, MD 44-289-063-3631 email@example.com|
|Royal Aberdeen Children's Hospital||Recruiting|
|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
|Contact: Veronica Neefjes 44-1224-550-217|
|Royal Hospital for Sick Children||Recruiting|
|Edinburgh, Scotland, United Kingdom, EH9 1LF|
|Contact: W. Hamish Wallace, MD 44-131-536-0426|
|Royal Hospital for Sick Children||Recruiting|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Contact: Milind D. Ronghe, MD 44-141-201-9309|
|Childrens Hospital for Wales||Recruiting|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 firstname.lastname@example.org|
|Principal Investigator:||Gareth Veal||University of Newcastle Upon-Tyne|