NCT02822404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2021

Completed
Last Updated

April 1, 2026

Status Verified

April 1, 2022

Enrollment Period

9.2 years

First QC Date

February 3, 2016

Last Update Submit

March 31, 2026

Conditions

Kidney Diseases

Keywords

kidney toxicity

Outcome Measures

Primary Outcomes (5)

  • Urinary cystatin C rate

    1 month

  • Urinary cystatin C rate

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

    6 months

  • Urinary cystatin C rate

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

    1 year

  • Urinary cystatin C rate

    2 years

  • Urinary cystatin C rate

    5 years

Secondary Outcomes (2)

  • Sensibility, specificity and positive predictive value for urinary CysC

    5 years

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

    5 years

Study Arms (1)

Urinary and blood sample

EXPERIMENTAL

Urinary and blood samples for cystatin C dosage

Dietary Supplement: Urinary and blood sample for Cystatine dosage

Interventions

Urinary and blood sample for Cystatine dosageDIETARY_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.

Urinary and blood sample

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

Related 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. 2021 Jan;68(1):e28747. doi: 10.1002/pbc.28747. Epub 2020 Oct 15.

    PMID: 33058496RESULT

MeSH Terms

Conditions

Kidney Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marlène Pasquet

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

July 4, 2016

Study Start

February 17, 2012

Primary Completion

May 4, 2021

Study Completion

May 4, 2021

Last Updated

April 1, 2026

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)