title: Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium.
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.
  
  
  METHODS
  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.
  
  
  METHODS
  The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.
  
  
  CONCLUSIONS
  This is the first report on a selenium randomized trial in bladder cancer patients.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00729287.
authors.affiliation: Department of General Practice, University of Leuven, ACHG-KU Leuven, Kapucijnenvoer 33, Blok J, bus 7001, 3000 Leuven, Belgium. Mieke.Goossens@med.kuleuven.be
authors.forename: Maria E
authors.initials: ME
authors.lastname: Goossens
authors.forename: Frank
authors.initials: F
authors.lastname: Buntinx
authors.forename: Steven
authors.initials: S
authors.lastname: Joniau
authors.forename: Koen
authors.initials: K
authors.lastname: Ackaert
authors.forename: Filip
authors.initials: F
authors.lastname: Ameye
authors.forename: Ignace
authors.initials: I
authors.lastname: Billiet
authors.forename: Johan
authors.initials: J
authors.lastname: Braeckman
authors.forename: Alex
authors.initials: A
authors.lastname: Breugelmans
authors.forename: Jochen
authors.initials: J
authors.lastname: Darras
authors.forename: Kurt
authors.initials: K
authors.lastname: Dilen
authors.forename: Lieven
authors.initials: L
authors.lastname: Goeman
authors.forename: Eliane
authors.initials: E
authors.lastname: Kellen
authors.forename: Bertrand
authors.initials: B
authors.lastname: Tombal
authors.forename: Siska
authors.initials: S
authors.lastname: Van Bruwaene
authors.forename: Ben
authors.initials: B
authors.lastname: Van Cleyenbreuge
authors.forename: Frank
authors.initials: F
authors.lastname: Van der Aa
authors.forename: Kris
authors.initials: K
authors.lastname: Vekemans
authors.forename: Hendrik
authors.initials: H
authors.lastname: Van Poppel
authors.forename: Maurice P
authors.initials: MP
authors.lastname: Zeegers
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000627:therapeutic use; D001530:Belgium / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology* / Q000517:prevention & control*; D015995:Prevalence; D018570:Risk Assessment; D012307:Risk Factors; D012643:Selenium / Q000627:therapeutic use*; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D055815:Young Adult
chemical_list: D000975:Antioxidants; D012643:Selenium