Actively Recruiting
Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children
Led by University of Colorado, Denver · Updated on 2025-10-15
152
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of the chemotherapies vincristine and doxorubicin on bladder function and urine composition in children who survived cancer. They aim to understand if these treatments are linked to bladder dysfunction symptoms using a survey called the Dysfunctional Voiding Symptom Score (DVSS). The study also compares non-invasive bladder tests and urine biomarkers between children with and without bladder dysfunction. Participants are childhood cancer survivors aged 5 to 13 years who received vincristine and/or doxorubicin chemotherapy at least one year before joining the study. They are grouped based on bladder dysfunction symptoms measured by DVSS, separated by gender and symptom severity. The study uses non-invasive urodynamic tests to evaluate urinary flow and urine proteomic screening to analyze proteins and peptides related to bladder health. During the study, children complete the DVSS survey, undergo non-invasive bladder function testing, and provide urine samples for biomarker analysis. Researchers will measure differences in bladder test patterns, urine residual volumes after voiding, urine flow rates, and urinary biomarkers over a 13-month period. This approach helps understand bladder health changes after chemotherapy in childhood cancer survivors.
CONDITIONS
Brief Title
Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 13 years old
- History of cancer
- Treated with chemotherapy including vincristine and/or doxorubicin
- Completed chemotherapy at least one year before enrollment and survey completion
You will not qualify if you...
- Primary pelvic tumor
- Pelvic irradiation
- Pre-existing bladder or bowel dysfunction
- Spinal defects
- Neurologic disorder
- Neuro-oncologic tumor or brain metastasis
- Treatment with cyclophosphamide or ifosfamide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo non-invasive urodynamic testing, urinary proteomic screening, and complete the Dysfunctional Voiding Symptom Score survey to evaluate bladder function and urine composition.
1 visit (in-person) for all tests and survey
Duration - Up to 13 months
Participants are observed for bladder function and urinary biomarker levels over a period of up to 13 months after diagnostic evaluation.
Follow-up assessments may occur during this period depending on study protocol
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
G
Gemma Beltran
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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