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NCT Number: NCT02822404

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

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.

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urinary and blood sample for Cystatine dosage

Dietary Supplement

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.

Primary outcomes

  1. Urinary cystatin C rate

    Time frame: 1 month

  2. Urinary cystatin C rate

    Time frame: 6 months

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

  3. Urinary cystatin C rate

    Time frame: 1 year

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

  4. Urinary cystatin C rate

    Time frame: 2 years

  5. Urinary cystatin C rate

    Time frame: 5 years

Secondary outcomes

  1. Sensibility, specificity and positive predictive value for urinary CysC

    Time frame: 5 years

    CysC is positive when it is detectable in urine, i.e when one or more reference biomarkers are positive

  2. Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: CysPed

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jul 4, 2016
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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