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NCT Number: 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

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.

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Key information

Conditions

Kidney Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood test for renal biomarkers

Other

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

urine test for renal biomarkers

Other

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)

Primary outcomes

  1. 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)

    Change in serum uromodulin levels (ng/ml)

Secondary outcomes

  1. 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 serum uromodulin levels (ng/ml)

  2. 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

    Change in urine uromodulin levels (ng/ml)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Stiftung für Krebskranke Kinder

Registry information

Official study 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)

Acronym: Kid-MaCareOnco

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2020
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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