Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-invasive Urodynamic Test (niUDS), Urinary proteomic screen, Dysfunctional Voiding Symptom Score Survey (DVSS).
- Who it may be relevant to
- Registry conditions: Survivors of Childhood Cancer, Bladder Dysfunction. Basic parameters: 5 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- 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.
Primary outcome measures
- Proportion of non-normal niUDS patterns between groups [Time frame: Immediately after niUDS done at the first visit]
- Proportion of Elevated Post-Void Residual (PVR) between groups [Time frame: 13 months]
- Compare Peak Flow Rates (Qmax) between groups [Time frame: 13 momths]
- Compare Average Flow Rates (Qavg) for age/gender [Time frame: 13 months]
- Compare Urinary Biomarker Levels between groups [Time frame: 13 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's Hospital Colorado — Aurora
Identifiers
NCT: NCT04993859 · 20-0680.cc · P30CA046934 · 1K23DK125673-01