BMC urology · 2012
Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium.
Клиническое исследование III фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
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.
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.