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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Survivors of Childhood Cancer; Bladder Dysfunction

Treatments: Diagnostic Test: Non-invasive Urodynamic Test (niUDS); Other: Dysfunctional Voiding Symptom Score Survey (DVSS); Diagnostic Test: Urinary proteomic screen

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04993859

1K23DK125673-01 (U.S. NIH Grant/Contract)

P30CA046934 (U.S. NIH Grant/Contract)

20-0680.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 5-10 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

Trial design

152 participants in 4 patient groups

Male Cancer Survivors with DVSS Score ≥ 9

Description:

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

Treatment:

Diagnostic Test: Urinary proteomic screen

Other: Dysfunctional Voiding Symptom Score Survey (DVSS)

Diagnostic Test: Non-invasive Urodynamic Test (niUDS)

Female Cancer Survivors with DVSS Score ≥ 6

Description:

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

Treatment:

Diagnostic Test: Urinary proteomic screen

Other: Dysfunctional Voiding Symptom Score Survey (DVSS)

Diagnostic Test: Non-invasive Urodynamic Test (niUDS)

Male Cancer Survivors with DVSS Score < 9

Description:

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

Treatment:

Diagnostic Test: Urinary proteomic screen

Other: Dysfunctional Voiding Symptom Score Survey (DVSS)

Diagnostic Test: Non-invasive Urodynamic Test (niUDS)

Female Cancer Survivors with DVSS Score < 6

Description:

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

Treatment:

Diagnostic Test: Urinary proteomic screen

Other: Dysfunctional Voiding Symptom Score Survey (DVSS)

Diagnostic Test: Non-invasive Urodynamic Test (niUDS)