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BMC Urol. 2012; 12: 8.
Published online Mar 21, 2012. doi:  10.1186/1471-2490-12-8
PMCID: PMC3352119
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 Goossens,corresponding author1,2 Frank Buntinx,1,3 Steven Joniau,4 Koen Ackaert,5 Filip Ameye,6 Ignace Billiet,7 Johan Braeckman,8 Alex Breugelmans,9 Jochen Darras,10 Kurt Dilen,11 Lieven Goeman,12 Eliane Kellen,13 Bertrand Tombal,14 Siska Van Bruwaene,4 Ben Van Cleyenbreuge,4 Frank Van der Aa,4 Kris Vekemans,10 Hendrik Van Poppel,4 and Maurice P Zeegers2,3
1Department of General Practice, University of Leuven, ACHG-KU Leuven, Kapucijnenvoer 33, Blok J, bus 7001, 3000 Leuven, Belgium
2Unit of Urologic and Genetic Epidemiology, University of Birmingham, Birmingham, UK
3Universiteit Maastricht, Maastricht, The Netherlands
4Department of Urology, UZ Leuven, Leuven, Belgium
5Department of Urology, Sint-Elisabethziekenhuis, Turnhout, Belgium
6Department of Urology, AZ Maria Middelares, Ghent, Belgium
7Department of Urology, AZ Groeninge, Kortrijk, Kortrijk, Belgium
8Department of Urology, UZ Brussel, Brussel, Belgium
9Department of Urology, Heilig Hart ziekenhuis, Leuven, Belgium
10Department of Urology, AZ Damiaan, Oostende, Belgium
11Department of Urology, Jessa ziekenhuis, Hasselt, Belgium
12Department of Urology, Kliniek Sint-Jan, Brussel, Belgium
13Leuven University Centre for Cancer Prevention (LUCK), Department of Urology, Cliniques universitaires Saint-Luc, Brussel, Belgium
14ACHG-KULeuven, Kapucijnenvoer 33 - Blok J - bus 7001, 3000 Leuven, Belgium
corresponding authorCorresponding author.
Maria E Goossens: Mieke.Goossens/at/med.kuleuven.be; Frank Buntinx: frank.buntinx/at/med.kuleuven.be; Steven Joniau: steven.joniau/at/uzleuven.be; Koen Ackaert: koenackaert/at/hotmail.com; Filip Ameye: Filip.Ameye/at/azmmsj.be; Ignace Billiet: ignace.billiet/at/azgroeninge.be; Johan Braeckman: johan.braeckman/at/uzbrussel.be; Alex Breugelmans: alexbreugelmans/at/scarlet.be; Jochen Darras: jdarras/at/azdamiaan.be; Kurt Dilen: kurt.dilen/at/jessazh.be; Lieven Goeman: LievenGoeman/at/gmail.com; Eliane Kellen: eliane.kellen/at/uzleuven.be; Bertrand Tombal: bertrand.tombal/at/uclouvain.be; Siska Van Bruwaene: siska.vanbruwaene/at/uzleuven.be; Ben Van Cleyenbreuge: ben.vancleynenbreugel/at/uzleuven.be; Frank Van der Aa: frank.vanderaa/at/uzleuven.be; Kris Vekemans: kris.vekemans/at/jessazh.be; Hendrik Van Poppel: hendrik.vanpoppel/at/uzleuven.be; Maurice P Zeegers: m.p.zeegers/at/bham.ac.uk
Received February 12, 2012; Accepted March 21, 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. 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
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