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临床试验/NCT02822404
NCT02822404已完成不适用

Assessment of Cystatin C as a Tubular and Glomerular Marker of Nephrotoxicity in Pediatric Oncology

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Urinary cystatin C rate

研究概览

简要总结

Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve renal toxic threats in children given their immature kidney. This toxicity is increased especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the available evaluation methods of the renal function could be very restrictive to perform on children. In this study, the investigators intend to test the use of the cystatin C as an effective and reliable biological marker of renal toxicity in children treated with cisplatin and / or ifosfamide.

详细描述

Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve renal toxic threats in children given their immature kidney. This toxicity is increased especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the evaluation of the renal function is carried out according to the clinical trial protocols and to the center practices. To date, the standard methods (eg. creatinine clearance), as well as the available predictive formula (eg. Schwartz formula) are not well adapted to monitor children renal function. Indeed, the reliability of these methods depends on several parameters such as the diet and the muscle mass and could be very restrictive to perform on children. To circumvent these practical difficulties, the investigators intend to use the cystatin C as a biological marker of renal toxicity in children treated with cisplatin and / or ifosfamide. This cysteine protease has witnessed an upsurge of interest as an endogenous glomerular filtration rate marker and could be a good candidate to assess tubular toxicity when measured in urine.

This study aims to describe the kinetic of the appearance of the urinary cystatin C and explore its proprieties as an early and cost-effective marker for glomerular and tubular renal toxicity in children. In addition, this method could allow enhancing the calculation models routinely used for glomerular filtration rate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children of 0 to18 years treated with cisplatin and / or ifosfamide in the hematology-oncology unit of Toulouse University Hospital of children regardless to the pathology they have been treated for
  • Children with more than 4kg
  • Written informed consent given by both parents or legal representative
  • Patient covered by a social security agreement

排除标准

  • Impossibility to monitor and follow up the patient until the foreseeable end of the treatment (geographic reasons, etc.)
  • Contraindication to EDTA clearance performing

结局指标

主要结局

Urinary cystatin C rate

时间窗: 5 years

Urinary cystatin C rate

时间窗: 1 month

Urinary cystatin C rate

时间窗: 6 months

at T2a and T2b (at the middle of treatment). It can depend on pathology

Urinary cystatin C rate

时间窗: 1 year

at T3 (at the end of treatment)It can depend on pathology

Urinary cystatin C rate

时间窗: 2 years

次要结局

  • Sensibility, specificity and positive predictive value for urinary CysC(5 years)
  • Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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