Bladder Cancer Clinical Trial

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

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.

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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.

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Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Estimated Enrollment:

152

Study ID:

NCT04993859

Recruitment Status:

Recruiting

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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Children's Hospital Colorado
Aurora Colorado, 80045, United States More Info
Gemma Beltran
Contact
720-777-4418
[email protected]
Nicholas Cost, MD
Principal Investigator

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Study is for people with:

Bladder Cancer

Estimated Enrollment:

152

Study ID:

NCT04993859

Recruitment Status:

Recruiting

Sponsor:


University of Colorado, Denver

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