Clinical trial NCT02822404: Description of the Cystatin C as an Early Nephrotoxic Bio-marker in Pediatric Oncology
Official title: Assessment of Cystatin C as a Tubular and Glomerular Marker of Nephrotoxicity in Pediatric Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Keywords: kidney toxicity
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 42
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Urinary cystatin C rate
timeFrame: 1 month
measure: Urinary cystatin C rate
timeFrame: 6 months
measure: Urinary cystatin C rate
timeFrame: 1 year
measure: Urinary cystatin C rate
timeFrame: 2 years
measure: Urinary cystatin C rate
timeFrame: 5 years
Secondary outcomes:
measure: Sensibility, specificity and positive predictive value for urinary CysC
timeFrame: 5 years
measure: Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)
timeFrame: 5 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Marlène Pasquet
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambert M, White-Koning M, Alonso M, Garnier A, Alphonsa G, Puiseux C, Munzer C, Berthier J, Malard L, Pasquet M, Chatelut E. Plasma cystatin C is a marker of renal glomerular injury in children treated with cisplatin or ifosfamide. Pediatr Blood Cancer. 2021 Jan;68(1):e28747. doi: 10.1002/pbc.28747. Epub 2020 Oct 15.