Clinical trial NCT04993859: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Survivors of Childhood Cancer
Bladder Dysfunction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Children's Hospital Colorado
First posted: 2021-08-06
Enrollment: 152
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Childhood cancer survivors that have been treated with a chemotherapy regimen including VCR and/or DOX, completion of chemotherapy at least one year prior to study enrollment and survey completion.

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.

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

Primary outcomes:
measure: Proportion of non-normal niUDS patterns between groups
timeFrame: Immediately after niUDS done at the first visit
measure: Proportion of Elevated Post-Void Residual (PVR) between groups
timeFrame: 13 months
measure: Compare Peak Flow Rates (Qmax) between groups
timeFrame: 13 momths
measure: Compare Average Flow Rates (Qavg) for age/gender
timeFrame: 13 months
measure: Compare Urinary Biomarker Levels between groups
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Nicholas Cost, MD
role: PRINCIPAL_INVESTIGATOR
References: