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Open Access Study protocol

Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium

Maria E Goossens12*, Frank Buntinx13, Steven Joniau4, Koen Ackaert5, Filip Ameye6, Ignace Billiet7, Johan Braeckman8, Alex Breugelmans9, Jochen Darras10, Kurt Dilen11, Lieven Goeman12, Eliane Kellen13, Bertrand Tombal14, Siska Van Bruwaene4, Ben Van Cleyenbreuge4, Frank Van der Aa4, Kris Vekemans10, Hendrik Van Poppel4 and Maurice P Zeegers23

Author Affiliations

1 Department of General Practice, University of Leuven, ACHG-KU Leuven, Kapucijnenvoer 33, Blok J, bus 7001, 3000 Leuven, Belgium

2 Unit of Urologic and Genetic Epidemiology, University of Birmingham, Birmingham, UK

3 Universiteit Maastricht, Maastricht, The Netherlands

4 Department of Urology, UZ Leuven, Leuven, Belgium

5 Department of Urology, Sint-Elisabethziekenhuis, Turnhout, Belgium

6 Department of Urology, AZ Maria Middelares, Ghent, Belgium

7 Department of Urology, AZ Groeninge, Kortrijk, Kortrijk, Belgium

8 Department of Urology, UZ Brussel, Brussel, Belgium

9 Department of Urology, Heilig Hart ziekenhuis, Leuven, Belgium

10 Department of Urology, AZ Damiaan, Oostende, Belgium

11 Department of Urology, Jessa ziekenhuis, Hasselt, Belgium

12 Department of Urology, Kliniek Sint-Jan, Brussel, Belgium

13 Leuven University Centre for Cancer Prevention (LUCK), Department of Urology, Cliniques universitaires Saint-Luc, Brussel, Belgium

14 ACHG-KULeuven, Kapucijnenvoer 33 - Blok J - bus 7001, 3000 Leuven, Belgium

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BMC Urology 2012, 12:8  doi:10.1186/1471-2490-12-8

Published: 21 March 2012

Abstract

Background

In Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8%). Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence.

Method

The SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at http://www.seleblat.org. webcite Patients are randomly assigned to selenium yeast (200 μg/day) supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study.

Design

The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.

Discussion

This is the first report on a selenium randomized trial in bladder cancer patients.

Trial registration

ClinicalTrials.gov identifier: NCT00729287

Keywords:
Selenium; Bladder cancer; Transitional Cell Carcinoma; Chemoprevention; Randomized clinical trial; Urology