Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Children's Cancer and Leukaemia Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00514345 |
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 | Intervention |
---|---|
Cancer-Related Problem/Condition Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Procedure: gene expression analysis Procedure: management of therapy complications Procedure: polymorphism analysis |
Study Type: | Observational |
Official Title: | CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children |
Estimated Enrollment: | 300 |
Study Start Date: | July 2007 |
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.
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Ireland | |
Our Lady's Hospital for Sick Children Crumlin | Recruiting |
Dublin, Ireland, 12 | |
Contact: Contact Person 353-1-409-6659 | |
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Amos Burke, MD 44-1223-348-151 | |
Birmingham Children's Hospital | Recruiting |
Birmingham, England, United Kingdom, B4 6NH | |
Contact: Martin W. English, MD 44-121-333-8412 martin.english@bch.nhs.uk | |
Bristol Royal Hospital for Children | Recruiting |
Bristol, England, United Kingdom, BS2 8BJ | |
Contact: Contact Person 44-117-342-0205 | |
Children's Hospital - Sheffield | Recruiting |
Sheffield, England, United Kingdom, S10 2TH | |
Contact: Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk | |
Queen's Medical Centre | Recruiting |
Nottingham, England, United Kingdom, NG7 2UH | |
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 63394 martin.hewitt@nuh.nhs.uk | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk | |
Leicester Royal Infirmary | Recruiting |
Leicester, England, United Kingdom, LE1 5WW | |
Contact: Johann Visser, MD 44-116-258-5309 johannes.visser@uhl-tr.nhs.uk | |
Oxford Radcliffe Hospital | Recruiting |
Oxford, England, United Kingdom, 0X3 9DU | |
Contact: Kate Wheeler, MD 44-186-522-1066 | |
Great Ormond Street Hospital for Children | Recruiting |
London, England, United Kingdom, WC1N 3JH | |
Contact: Gill Levitt, MD 44-20-7405-9200 ext. 0073 | |
Royal Liverpool Children's Hospital, Alder Hey | Recruiting |
Liverpool, England, United Kingdom, L12 2AP | |
Contact: Heather P. McDowell, MD 44-151-293-3679 | |
Royal Manchester Children's Hospital | Recruiting |
Manchester, England, United Kingdom, M27 4HA | |
Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Mary Taj, MD 44-20-8642-6011 ext. 3089 | |
Sir James Spence Institute of Child Health | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
Contact: Juliet Hale, MD 44-191-282-4101 j.p.hale@ncl.ac.uk | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942 | |
University College Hospital | Recruiting |
London, England, United Kingdom, NW1 2PCE | |
Contact: Maria Michelagnoli, MD 44-20-7380-9064 maria.michelagnoli@uclh.nhs.uk | |
United Kingdom, Northern Ireland | |
Royal Belfast Hospital for Sick Children | Recruiting |
Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk | |
United Kingdom, Scotland | |
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 |
Glasgow, Scotland, United Kingdom, G3 8SJ | |
Contact: Milind D. Ronghe, MD 44-141-201-9309 | |
Royal Hospital for Sick Children | Recruiting |
Edinburgh, Scotland, United Kingdom, EH9 1LF | |
Contact: W. Hamish Wallace, MD 44-131-536-0426 | |
United Kingdom, Wales | |
Childrens Hospital for Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 heidi.traunecker@cardiffandvale.wales.nhs.uk |
Principal Investigator: | Gareth Veal | University of Newcastle Upon-Tyne |
Study ID Numbers: | CDR0000560128, CCLG-PK-2007-02, EU-20743 |
Study First Received: | August 8, 2007 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00514345 |
Health Authority: | Unspecified |
chemotherapeutic agent toxicity localized Ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor nonmetastatic childhood soft tissue sarcoma unspecified childhood solid tumor, protocol specific |
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma previously treated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma |
Neuroectodermal Tumors, Primitive Ewing's family of tumors Malignant mesenchymal tumor Recurrence Soft tissue sarcomas Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue Ifosfamide Ewing's sarcoma |
Sarcoma, Ewing's Peripheral neuroectodermal tumor Neoplasms, Germ Cell and Embryonal Sarcoma Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Isophosphamide mustard Rhabdomyosarcoma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |