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

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

Recruiting
5-10 years
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Survivors of Childhood Cancer
    Bladder Dysfunction

NCT04993859

University of Colorado, Denver

27 January 2024

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