Kidney DiseasesCysPedNCT02822404
Description of the Cystatin C as an Early Nephrotoxic Bio-marker in Pediatric Oncology
A study testing Urinary and blood sample for Cystatine dosage in people with Kidney Diseases, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Urinary and blood sample for Cystatine dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2012to 4 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Impossibility to monitor and follow up the patient until the foreseeable end of the treatment (geographic reasons, etc.)
- Contraindication to EDTA clearance performing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cystatin C as a Tubular and Glomerular Marker of Nephrotoxicity 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.
Read the 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.
- Conditions
- Kidney Diseases
- Being tested
- Urinary and blood sample for Cystatine dosage
- Keywords
- kidney toxicity
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Urinary and blood sample | Experimental | Urinary and blood samples for cystatin C dosage Receives: Dietary Supplement: Urinary and blood sample for Cystatine dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary cystatin C rate
Measured: 1 month
Urinary cystatin C rate
at T2a and T2b (at the middle of treatment). It can depend on pathology
Measured: 6 months
Urinary cystatin C rate
at T3 (at the end of treatment)It can depend on pathology
Measured: 1 year
Urinary cystatin C rate
Measured: 2 years
Urinary cystatin C rate
Measured: 5 years
Secondary outcomes (2)
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
Measured: 5 years
Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start17 Feb 2012
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlène Pasquet, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822404
- Sponsor's protocol ID
- 11 308 03
- Other IDs
- 2011-A01126-35
- Acronym
- CysPed
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2016
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33058496
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cystatin C as a Tubular and Glomerular Marker of Nephrotoxicity in Pediatric Oncology
- ClinicalTrials.gov ID
- NCT02822404
- Acronym / sponsor ID
- CysPed / 11 308 03
- Conditions
- Kidney Diseases
- Keywords
- kidney toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 17 Feb 2012 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urinary and blood sample | Experimental | Dietary Supplement: Urinary and blood sample for Cystatine dosageUrinary and blood samples for cystatin C dosage |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Impossibility to monitor and follow up the patient until the foreseeable end of the treatment (geographic reasons, etc.)
- Contraindication to EDTA clearance performing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary and blood sample for Cystatine dosageUrinary 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. | Dietary supplement | Urinary and blood sample |
Primary outcome
Urinary cystatin C rate
Time frame: 1 month
Urinary cystatin C rate
Time frame: 6 months
at T2a and T2b (at the middle of treatment). It can depend on pathology
Urinary cystatin C rate
Time frame: 1 year
at T3 (at the end of treatment)It can depend on pathology
Urinary cystatin C rate
Time frame: 2 years
Urinary cystatin C rate
Time frame: 5 years
2 secondary outcomes
Sensibility, specificity and positive predictive value for urinary CysC
Time frame: 5 years
Predictive value for Glomerular Filtration Rate with blood rate of CysC (with Bouvet calculation method)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Results publication: PubMed 33058496Lambert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlène Pasquet principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary and blood sample for Cystatine dosage in people with Kidney Diseases, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary cystatin C rate (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.