Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

NCT ID: NCT04993859

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-02

Study Completion Date

2026-07-09

Brief Summary

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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

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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.

Conditions

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Survivors of Childhood Cancer Bladder Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Male Cancer Survivors with DVSS Score ≥ 9

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

Non-invasive Urodynamic Test (niUDS)

Intervention Type DIAGNOSTIC_TEST

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

Urinary proteomic screen

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type OTHER

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

Female Cancer Survivors with DVSS Score ≥ 6

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

Non-invasive Urodynamic Test (niUDS)

Intervention Type DIAGNOSTIC_TEST

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

Urinary proteomic screen

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type OTHER

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

Male Cancer Survivors with DVSS Score < 9

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

Non-invasive Urodynamic Test (niUDS)

Intervention Type DIAGNOSTIC_TEST

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

Urinary proteomic screen

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type OTHER

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

Female Cancer Survivors with DVSS Score < 6

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

Non-invasive Urodynamic Test (niUDS)

Intervention Type DIAGNOSTIC_TEST

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

Urinary proteomic screen

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type OTHER

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

Interventions

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Non-invasive Urodynamic Test (niUDS)

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Dysfunctional Voiding Symptom Score Survey (DVSS)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Children's Hospital Colorado

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicholas Cost, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gemma Beltran

Role: CONTACT

(720) 777-4418

Facility Contacts

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Gemma Beltran

Role: primary

(720) 777-4418

Other Identifiers

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P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1K23DK125673-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-0680.cc

Identifier Type: -

Identifier Source: org_study_id

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