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

University Hospital, Basel, Switzerland6 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Kidney Impairment

Interventions

blood test for renal biomarkersOTHER

blood test for renal biomarkers (uromodulin,Neutrophil gelatinase-associated lipocalin, beta-trace protein, creatinine, cystatin C)

urine test for renal biomarkersOTHER

urine test for renal biomarkers (uromodulin, alpha-1 microglobulin, retinol-binding protein, Neutrophil gelatinase-associated lipocalin (NGAL), beta-trace protein, cylinder, albumin, immunoglobulin G (IgG), transferrin, creatinine)

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Children's Hospital Basel (UKBB), University of Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Change in serum uromodulin levels (ng/ml)

Time frame: 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

Change in serum uromodulin levels (ng/ml)

Time frame: 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

Change in urine uromodulin levels (ng/ml)

Time frame: 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

Data from ClinicalTrials.gov

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