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

Kidney Diseases Clinical Trial

— CysPed  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822404
• Other study ID #: 11 308 03
• Status: Completed
• Phase: N/A
• Start date: February 17, 2012
• Est. completion date: May 4, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Dietary Supplement:
• Urinary and blood sample for Cystatine dosage
Urinary and blood cystatin C are sampled in patient with nephrotoxic risks before the treatment beginning, after the first course of chemotherapy, in the middle and at the end of the treatment. A follow up assessment is also required at 2 and 5 years. The cystatin C measurements are compared to traditional nephrology markers. Their sampling requires additional blood and urinary collection but involve minimal risks for patient.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary cystatin C rate		1 month
Primary	Urinary cystatin C rate	at T2a and T2b (at the middle of treatment). It can depend on pathology	6 months
Primary	Urinary cystatin C rate	at T3 (at the end of treatment)It can depend on pathology	1 year
Primary	Urinary cystatin C rate		2 years
Primary	Urinary cystatin C rate		5 years
Secondary	Sensibility, specificity and positive predictive value for urinary CysC	CysC is positive when it is detectable in urine, i.e when one or more reference biomarkers are positive	5 years
Secondary	Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)		5 years