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

作者：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

来源：BMC Urology, 2012, 12: 8.

DOI：10.1186/1471-2490-12-8

• Selenium
• Bladder cancer
• Transitional Cell Carcinoma
• Chemoprevention
• Randomized clinical trial
• Urology

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. %26lt;br%26gt;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 mu g/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. %26lt;br%26gt;Design: The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial. %26lt;br%26gt;Discussion: This is the first report on a selenium randomized trial in bladder cancer patients. %26lt;br%26gt;Trial registration: ClinicalTrials.gov identifier: NCT00729287

• 出版日期2012-3-21
• 单位KU Leuven