NCT04197089

Biological Effect of Vitamin D in Patients With Urothelial Carcinoma

Pilot Study of the Biological Effects of Vitamin D in Patients With Resectable Urinary Tract Urothelial Carcinoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study population will be 50 women or men diagnosed with urothelial cancer candidates to undergo cystectomy as part of their antitumor treatment. The main objective of the study is to determine the biological effect of Vitamin D on tumor tissue phenotype; for thus, all subjects enrolled in the study will take Vitamin D supplementation 4 weeks prior undergoing surgery. Urothelial tissue will be obtained from the surgical procedure and will be studied for the Vitamin D effect on cancer cell, compared with that urothelial tissue biopsy obtained in the moment of cancer diagnosis.

Detailed 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 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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Vitamin D	First dose of 10.000 IU Vitamin D at baseline visit for all patients; stratification of treatment (10.000 or 50.000 IU Vitamin D) depending base 25(OH)Vitamin D levels. Treatment weekly during 4 weeks before scheduled cystectomy

Timeline

• Start date: 2020-02-11
• Primary completion: 2021-11-22
• Completion: 2021-11-22
• First posted: 2019-12-12
• Last updated: 2022-08-03

Locations

1 site across 1 country: Spain