Evaluating the effects of chemotherapy on bladder function in childhood cancer survivors
Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children
This study is testing how two chemotherapy drugs might affect bladder function in children aged 5-13 who have survived cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 152 (estimated) |
| Ages | 5 Years to 13 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | chemotherapy, Cyclophosphamide, doxorubicin |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04993859 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how two specific chemotherapy drugs, vincristine and doxorubicin, impact bladder function and urine composition in children who have survived cancer. The study will involve children aged 5-13 years who have completed chemotherapy at least one year prior and will utilize non-invasive urodynamic testing, urinary proteomic screening, and a survey to evaluate bladder dysfunction symptoms. The researchers hypothesize that survivors exposed to these chemotherapies will report higher incidences of bladder dysfunction and show significant differences in urinary biomarkers compared to those without such symptoms.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-13 years who have a history of cancer and have received vincristine and/or doxorubicin chemotherapy.
Not a fit: Patients with primary pelvic tumors, pelvic irradiation, or pre-existing bladder/bowel dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of bladder dysfunction in childhood cancer survivors.
How similar studies have performed: While there is limited data on this specific approach, studies on chemotherapy effects on bladder function in adults have shown varying results, indicating that this area may still hold novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Nicholas Cost, MD — Children's Hospital Colorado
- Study coordinator: Gemma Beltran
- Email: gemma.beltran@childrenscolorado.org
- Phone: (720) 777-4418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.