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

  • STATUS
    Recruiting
  • End date
    Jul 9, 2025
  • participants needed
    152
  • sponsor
    University of Colorado, Denver
Updated on 4 October 2022

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.

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.

Details
Condition Bladder Dysfunction, Survivors of Childhood Cancer
Treatment Non-invasive Urodynamic Test (niUDS), Urinary proteomic screen, Dysfunctional Voiding Symptom Score Survey (DVSS)
Clinical Study IdentifierNCT04993859
SponsorUniversity of Colorado, Denver
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Children aged 5-10 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
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