NCT04993859

Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 152 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 5 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition.

Detailed description

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition. The global hypothesis is that childhood cancer survivors with prior exposure to systemic vincristine (VCR) and/or doxorubicin (DOX) report an increased incidence of bladder dysfunction (BD) symptoms on the Dysfunctional Voiding Symptom Score (DVSS) survey. We expect to observe differences in non-invasive urodynamic (niUDS) testing between childhood cancer survivors with BD symptoms on the DVSS versus those without BD symptoms on DVSS. We also expect to observe statistically significant differences in the urinary levels of known urinary biomarkers of BD (NGF, ATP and BDNF) of patients with evidence of BD compared to those without BD on the DVSS. We also expect to observe rational differences in the urinary proteome of patients between those with and without BD.

Conditions

• Survivors of Childhood Cancer
• Bladder Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Non-invasive Urodynamic Test (niUDS)	A noninvasive urodynamics is a simple test used to evaluate urinary flow.
DIAGNOSTIC_TEST	Urinary proteomic screen	Urine proteomics is a powerful platform to identify urinary excreted proteins and peptides in different stages of disease or therapy and to determine their quantity, functions, and interaction.
OTHER	Dysfunctional Voiding Symptom Score Survey (DVSS)	The Dysfunctional Voiding Symptom Score provides accurate and objective grading of voiding behaviors of children.

Timeline

• Start date: 2021-06-02
• Primary completion: 2026-07-09
• Completion: 2026-07-09
• First posted: 2021-08-06
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States