Recruiting

Vincristine & Doxorubicin

Sponsor:

University of Colorado, Denver

Code:

NCT04993859

Conditions

Survivors of Childhood Cancer

Bladder Dysfunction

Eligibility Criteria

Sex: All

Age: 5 - 13

Healthy Volunteers: Not accepted

Interventions

Non-invasive Urodynamic Test (niUDS)

Urinary proteomic screen

Dysfunctional Voiding Symptom Score Survey (DVSS)

Study Details

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.

Conditions

Survivors of Childhood Cancer

Bladder Dysfunction

Study ID

NCT04993859

Start date

Jun 2, 2021

Status verified date

Sep, 2026

Completion date

Jul 9, 2031

Anticipated

Primary completion date

Jul 9, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 13

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

152 participants

Anticipated

Interventions and Outcome Measures

Arms

Male Cancer Survivors with DVSS Score ≥ 9

Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS

Female Cancer Survivors with DVSS Score ≥ 6

Childhood cancer survivors treated with DOX and/or VCR with evidence of BD on DVSS

Male Cancer Survivors with DVSS Score < 9

Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS

Female Cancer Survivors with DVSS Score < 6

Childhood cancer survivors treated with DOX and/or VCR without evidence of BD on DVSS

Interventions

Non-invasive Urodynamic Test (niUDS)

A noninvasive urodynamics is a simple test used to evaluate urinary flow.

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.

Dysfunctional Voiding Symptom Score Survey (DVSS)

The Dysfunctional Voiding Symptom Score provides accurate and objective grading of voiding behaviors of children.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Gemma Beltran

(720) 777-4418gemma.beltran@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Gemma Beltran

(720) 777-4418gemma.beltran@childrenscolorado.org

Principal Investigator:

Nicholas Cost, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-09-09.