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

BMC Urology. 2012;12(1):8 DOI 10.1186/1471-2490-12-8

 

Journal Homepage

Journal Title: BMC Urology

ISSN: 1471-2490 (Online)

Publisher: BMC

LCC Subject Category: Medicine: Internal medicine: Specialties of internal medicine: Diseases of the genitourinary system. Urology

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS


Goossens Maria E

Buntinx Frank

Joniau Steven

Ackaert Koen

Ameye Filip

Billiet Ignace

Braeckman Johan

Breugelmans Alex

Darras Jochen

Dilen Kurt

Goeman Lieven

Kellen Eliane

Tombal Bertrand

Van Bruwaene Siska

Van Cleyenbreuge Ben

Van der Aa Frank

Vekemans Kris

Van Poppel Hendrik

Zeegers Maurice P

EDITORIAL INFORMATION

Open peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 21 weeks

 

Abstract | Full Text

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Method</p> <p>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 <url>http://www.seleblat.org.</url> 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.</p> <p>Design</p> <p>The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.</p> <p>Discussion</p> <p>This is the first report on a selenium randomized trial in bladder cancer patients.</p> <p>Trial registration</p> <p>ClinicalTrials.gov identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00729287">NCT00729287</a></p>