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

NCT04308642 | Completed

• 1 other identifier: 2019-02143; ks19Pfister
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in serum uromodulin levels (ng/ml)

  Change in serum uromodulin levels (ng/ml)

  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 (2)

• Change in serum uromodulin levels (ng/ml)

  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)

  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

Interventions

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)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Stiftung für Krebskranke Kinder: collaborator

Study Sites (1)

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

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Hematologic Tests; Urinalysis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Marc Pfister, Prof MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 16, 2020
• Study Start: October 22, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CH (1)