Clinical trial NCT04308642: Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy
Official title: Pilot Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy (Kid-MaCare Oncology)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Impairment
Keywords: nephrotoxic chemotherapy
pediatric cancer patients
renal adverse drug events
renal function
renal tubular injury
Uromodulin
drug related kidney injury
kidney markers
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Stiftung für Krebskranke Kinder
First posted: 2020-03-16
Enrollment: 6
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric cancer patients aged 0-18 years treated at the hematology-oncology at the University Children's Hospital Basel (UKBB) with a cancer diagnosis, that indicates a nephrotoxic chemotherapy including the drugs High Dose MTX (HD-MTX), ifosfamide, cis- and carboplatin.

Brief summary: This study is to investigate blood and urine kidney injury markers (especially Uromodulin) in pediatric cancer patients treated with nephrotoxic chemotherapy. Uromodulin is a marker to detect and monitor tubular injury and renal function.


Eligibility criteria: Inclusion Criteria:

* signed informed consent by their-selves (≥ 14 years) or their legal representatives (\< 14 years or in case of lacking capacity of judgement)
* cancer diagnosis, that indicates a nephrotoxic chemotherapy including the drugs High Dose MTX (HD-MTX), ifosfamide, cis- and carboplatin.

Exclusion Criteria:

* critically-ill patients with inotropic and/or vasopressor drugs
* signs of severe Sepsis
* receiving other nephrotoxic drugs parallel to the chemotherapy cycle

Primary outcomes:
measure: Change in serum uromodulin levels (ng/ml)
timeFrame: from baseline (i.e. prior to first nephrotoxic chemotherapy cycle) to post-baseline (i.e. at the end of the first nephrotoxic chemotherapy cycle exposure); depending on chemotherapy protocol (maximally 24 - 72 hours)
Secondary outcomes:
measure: Change in serum uromodulin levels (ng/ml)
timeFrame: at baseline (i.e. prior to first nephrotoxic chemotherapy cycle) and post-baseline (i.e. before, dur-ing and at the end of each nephrotoxic chemotherapy cycle),maximally 6- 9 months
measure: Change in urine uromodulin levels (ng/ml)
timeFrame: at baseline (i.e. prior to first nephrotoxic chemotherapy cycle) and post-baseline (i.e. before, dur-ing and at the end of each nephrotoxic chemotherapy cycle), maximally 6- 9 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel (UKBB), University of Basel
Study officials:
affiliation: University Children's Hospital Basel (UKBB), University of Basel
name: Marc Pfister, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: