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

NCT ID: NCT04308642

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-22

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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blood test for renal biomarkers

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

Intervention Type OTHER

urine test for renal biomarkers

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)

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stiftung für Krebskranke Kinder

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Pfister, Prof MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2019-02143; ks19Pfister

Identifier Type: -

Identifier Source: org_study_id

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