Clinical trial · Observational
CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide
CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children
NCT00514345CI-TRIAL-00011721unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene expression analysis | Genetic | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- CYP3A5 genotype
- measure
- Renal function and nephrotoxicity
- measure
- Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity
Secondary outcomes (1)
- measure
- Comparison of measured glomerular filtration rate (GFR) with the Cole model
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Received ifosfamide before the age of 21 as part of treatment for cancer including, but not limited to, any of the following:
* Ewing sarcoma
* Rhabdomyosarcoma
* Non-rhabdomyosarcoma soft tissue sarcoma
* No renal infiltration by tumor at any stage of illness
* May have been treated on one of the following clinical trials:
* Euro-Ewing-Intergroup-EE99
* SIOP-MMT-95
* Patients who received CEV chemotherapy (carboplatin, epirubicin, and vincristine) on strategy 952 or 953 are not eligible
* CCLG-EPSSG-NRSTS-2005
* 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 ifosfamideReferences
Publications (0)
Data not yet available
No reference posted for this study.