Actively Recruiting

Age: 5Years - 13Years
All Genders
ID04993859

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

Age: 5Years - 13Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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