Description of the Cystatin C as an Early Nephrotoxic Bio-marker in Pediatric Oncology (CysPed)
Primary Purpose
Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urinary and blood sample for Cystatine dosage
Sponsored by
About this trial
This is an interventional diagnostic trial for Kidney Diseases focused on measuring kidney toxicity
Eligibility Criteria
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
Sites / Locations
- CHU Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urinary and blood sample
Arm Description
Urinary and blood samples for cystatin C dosage
Outcomes
Primary Outcome Measures
Urinary cystatin C rate
Urinary cystatin C rate
at T2a and T2b (at the middle of treatment). It can depend on pathology
Urinary cystatin C rate
at T3 (at the end of treatment)It can depend on pathology
Urinary cystatin C rate
Urinary cystatin C rate
Secondary Outcome Measures
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
Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)
Full Information
NCT ID
NCT02822404
First Posted
February 3, 2016
Last Updated
April 22, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02822404
Brief Title
Description of the Cystatin C as an Early Nephrotoxic Bio-marker in Pediatric Oncology
Acronym
CysPed
Official Title
Assessment of Cystatin C as a Tubular and Glomerular Marker of Nephrotoxicity in Pediatric Oncology
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2012 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
kidney toxicity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urinary and blood sample
Arm Type
Experimental
Arm Description
Urinary and blood samples for cystatin C dosage
Intervention Type
Dietary Supplement
Intervention Name(s)
Urinary and blood sample for Cystatine dosage
Intervention Description
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 Outcome Measure Information:
Title
Urinary cystatin C rate
Time Frame
1 month
Title
Urinary cystatin C rate
Description
at T2a and T2b (at the middle of treatment). It can depend on pathology
Time Frame
6 months
Title
Urinary cystatin C rate
Description
at T3 (at the end of treatment)It can depend on pathology
Time Frame
1 year
Title
Urinary cystatin C rate
Time Frame
2 years
Title
Urinary cystatin C rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Sensibility, specificity and positive predictive value for urinary CysC
Description
CysC is positive when it is detectable in urine, i.e when one or more reference biomarkers are positive
Time Frame
5 years
Title
Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)
Time Frame
5 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlène Pasquet
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33058496
Citation
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.
Results Reference
result
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Description of the Cystatin C as an Early Nephrotoxic Bio-marker in Pediatric Oncology
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