Spots Global Cancer Trial Database for Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

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Trial Identification

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

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

Study ID: NCT04993859

Conditions

Survivors of Childhood Cancer

Bladder Dysfunction

Interventions

Non-invasive Urodynamic Test (niUDS)

Urinary proteomic screen

Dysfunctional Voiding Symptom Score Survey (DVSS)

Study Description

Brief 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.