Biological Effect of Vitamin D in Patients With Urothelial Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Urothelial Carcinoma
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Treatment stratified with 10.000 IU or 50.000 IU Vitamin D depending of baseline 25(OH)Vitamin D plasmatic levelsMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The study will enroll 50 patients (older than 18 and younger than 80 years old), recently diagnosed with urothelial cancer and candidates to undergo radical cystectomy or nephroureterectomy. At the baseline visit, a blood sample will be obtained for 25OH-VitD analysis and all subjects will receive f...
The study will enroll 50 patients (older than 18 and younger than 80 years old), recently diagnosed with urothelial cancer and candidates to undergo radical cystectomy or nephroureterectomy. At the baseline visit, a blood sample will be obtained for 25OH-VitD analysis and all subjects will receive first dose of 10.000 IU Vitamin D. Depending of basal plasmatic Vitamin D value, patients will be stratified in either 10.000 IU treatment (25OH-VitD ? 20 ng/ml) or either 50.000 UI treatment dose (25OH-VitD < 20 ng/ml). Treatment will consist of 4 doses taken weekly before their scheduled cystectomy. Last study follow-up visit will be 4 weeks post-surgery. Urothelial tumor tissue collected on surgery will be used to evaluate the expression of tumor differentiation and Vitamin D markers, using genomics and proteomics approaches. Blood sample will also be collect throughout the study to evaluate the pharmacokinetics of Vitamin D in plasma and the expression of Vitamin D target genes in peripheral blood leukocytes.
Tracking Information
- NCT #
- NCT04197089
- Collaborators
- Spanish Clinical Research Network - SCReN
- Centro Nacional de Investigaciones Oncologicas CARLOS III
- Fundació Institut Germans Trias i Pujol
- Investigators
- Study Chair: Francisco Xavier Real, MD, PhD Centro Nacional de Investigaciones Oncologicas CARLOS III (CNIO) Study Director: Albert Font Pous, MD, PhD Institut Català Oncologia (ICO)
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