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

Not Applicable

Completed

• Conditions: Kidney Diseases
• Interventions: Dietary Supplement: Urinary and blood sample for Cystatine dosage

• Registration Number: NCT02822404
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2012-02-17
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-04
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urinary and blood sample	Urinary and blood sample for Cystatine dosage	Urinary and blood samples for cystatin C dosage

Primary Outcome Measures

Name	Time	Method
Urinary cystatin C rate	5 years

Secondary Outcome Measures

Name	Time	Method
Sensibility, specificity and positive predictive value for urinary CysC	5 years	CysC is positive when it is detectable in urine, i.e when one or more reference biomarkers are positive
Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)	5 years

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France