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NCT04993859Recruiting

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

University of Colorado, Denver

Start Date

6/2/2021

Completion Date

7/9/2026

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.

Eligibility Criteria

Age Range: 5 years to 13 years

Inclusion Criteria: * Children aged 5-13 years old * A history of cancer * Treatment with a chemotherapy regimen including VCR and/or DOX * Completion of chemotherapy at least one year prior to study enrollment and survey completion. Exclusion Criteria: * Patients with a: * Primary pelvic tumor * Pelvic irradiation * Pre-existing bladder/bowel dysfunction * Spinal defects * Neurologic disorder * Neuro-oncologic tumor or brain metastasis * Cyclophosphamide or ifosfamide therapy

Interventions

DIAGNOSTIC_TEST

Non-invasive Urodynamic Test (niUDS)

DIAGNOSTIC_TEST

Urinary proteomic screen

OTHER

Dysfunctional Voiding Symptom Score Survey (DVSS)

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Conditions

Survivors of Childhood CancerBladder Dysfunction

Locations

Children's Hospital Colorado

Aurora, Colorado 80045

United States