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

M.E. Goossens; F. Buntinx; S. Joniau; K. Ackaert; F. Ameye; I. Billiet; J. Braeckman; A. Breugelmans; J. Darras; K. Dilen; L. Goeman; E. Kellen; B. Tombal; S. van Bruwaene; B. van Cleyenbreuge; F. van der Aa; K. Vekemans; H. van Poppel; M.P. Zeegers

doi:10.1186/1471-2490-12-8

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

M.E. Goossens^*, F. Buntinx, S. Joniau, K. Ackaert, F. Ameye, I. Billiet, J. Braeckman, A. Breugelmans, J. Darras, K. Dilen, L. Goeman, E. Kellen, B. Tombal, S. van Bruwaene, B. van Cleyenbreuge, F. van der Aa, K. Vekemans, H. van Poppel, M.P. Zeegers

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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 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.

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

Original language	English
Article number	8
Number of pages	8
Journal	BMC Urology
Volume	12
Issue number	1
DOIs	https://doi.org/10.1186/1471-2490-12-8
Publication status	Published - 21 Mar 2012

Keywords

Selenium
Bladder cancer
Transitional Cell Carcinoma
Chemoprevention
Randomized clinical trial
Urology
PROSTATE-CANCER
SERUM SELENIUM
VITAMIN-E
TOENAIL SELENIUM
PREVENTION TRIAL
TRANSURETHRAL RESECTION
LACTOBACILLUS-CASEI
CLINICAL-TRIAL
RISK
SUPPLEMENTATION

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Cite this

Goossens, M. E., Buntinx, F., Joniau, S., Ackaert, K., Ameye, F., Billiet, I., Braeckman, J., Breugelmans, A., Darras, J., Dilen, K., Goeman, L., Kellen, E., Tombal, B., van Bruwaene, S., van Cleyenbreuge, B., van der Aa, F., Vekemans, K., van Poppel, H., & Zeegers, M. P. (2012). 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, 12(1), Article 8. https://doi.org/10.1186/1471-2490-12-8

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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.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.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, PROSTATE-CANCER, SERUM SELENIUM, VITAMIN-E, TOENAIL SELENIUM, PREVENTION TRIAL, TRANSURETHRAL RESECTION, LACTOBACILLUS-CASEI, CLINICAL-TRIAL, RISK, SUPPLEMENTATION",

author = "M.E. Goossens and F. Buntinx and S. Joniau and K. Ackaert and F. Ameye and I. Billiet and J. Braeckman and A. Breugelmans and J. Darras and K. Dilen and L. Goeman and E. Kellen and B. Tombal and {van Bruwaene}, S. and {van Cleyenbreuge}, B. and {van der Aa}, F. and K. Vekemans and {van Poppel}, H. and M.P. Zeegers",

year = "2012",

month = mar,

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doi = "10.1186/1471-2490-12-8",

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Goossens, ME, Buntinx, F, Joniau, S, Ackaert, K, Ameye, F, Billiet, I, Braeckman, J, Breugelmans, A, Darras, J, Dilen, K, Goeman, L, Kellen, E, Tombal, B, van Bruwaene, S, van Cleyenbreuge, B, van der Aa, F, Vekemans, K, van Poppel, H & Zeegers, MP 2012, '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, vol. 12, no. 1, 8. https://doi.org/10.1186/1471-2490-12-8

TY - JOUR

T1 - Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium

AU - Goossens, M.E.

AU - Buntinx, F.

AU - Joniau, S.

AU - Ackaert, K.

AU - Ameye, F.

AU - Billiet, I.

AU - Braeckman, J.

AU - Breugelmans, A.

AU - Darras, J.

AU - Dilen, K.

AU - Goeman, L.

AU - Kellen, E.

AU - Tombal, B.

AU - van Bruwaene, S.

AU - van Cleyenbreuge, B.

AU - van der Aa, F.

AU - Vekemans, K.

AU - van Poppel, H.

AU - Zeegers, M.P.

PY - 2012/3/21

Y1 - 2012/3/21

N2 - 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 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.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

AB - 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 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.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

KW - Selenium

KW - Bladder cancer

KW - Transitional Cell Carcinoma

KW - Chemoprevention

KW - Randomized clinical trial

KW - Urology

KW - PROSTATE-CANCER

KW - SERUM SELENIUM

KW - VITAMIN-E

KW - TOENAIL SELENIUM

KW - PREVENTION TRIAL

KW - TRANSURETHRAL RESECTION

KW - LACTOBACILLUS-CASEI

KW - CLINICAL-TRIAL

KW - RISK

KW - SUPPLEMENTATION

U2 - 10.1186/1471-2490-12-8

DO - 10.1186/1471-2490-12-8

M3 - Article

SN - 1471-2490

VL - 12

JO - BMC Urology

JF - BMC Urology

IS - 1

M1 - 8

ER -