Description of the Cystatin C as an Early Nephrotoxic Bio-marker in Pediatric Oncology (CysPed)

Toulouse University Hospital

Status: Completed

Conditions: Kidney Diseases

Treatments: Dietary Supplement: Urinary and blood sample for Cystatine dosage

Study type: Interventional

Funder types: Other

Identifiers

NCT02822404

11 308 03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Urinary and blood sample

Experimental group

Description:

Urinary and blood samples for cystatin C dosage

Treatment:

Dietary Supplement: Urinary and blood sample for Cystatine dosage