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17 May 2012
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| [ Print-friendly version ] |
| Bladder Cancer Prognosis Programme (incorporating SELENIB trial) |
| ISRCTN | ISRCTN13889738 |
| ClinicalTrials.gov identifier | NCT00553215 |
| Public title | Bladder Cancer Prognosis Programme (incorporating SELENIB trial) |
| Scientific title | |
| Acronym | BCPP, SELENIB |
| Serial number at source | BCPP 2005-01 |
| Study hypothesis |
Objectives:
1. To assess the effect of lifestyle factors (such as smoking, dietary habits, fluid intake and environmental exposures) on the recurrence and progression of bladder cancer 2. To investigate whether selenium and/or vitamin E (aplha-tocopherol) supplementation reduces the risk of recurrence and progression of superficial bladder cancer 3. To study health-related quality of life and its association with recurrence and progression of bladder cancer 4. To establish a bladder cancer tissue bank (that will comprise of blood, urine, and bladder tissue) 5. To study the predictive effect of molecular markers on the recurrence and progression of bladder cancer As of 15/02/2011 the target participant number has been updated from 3400 to 2700. |
| Lay summary | http://www.cancerhelp.org.uk/trials/a-study-looking-at-risk-factors-for-bladder-cancer-coming-back |
| Ethics approval | Nottingham Research Ethics Committee (REC) 2 in October 2005, reference number: 05/Q2404/173 |
| Study design | Double-blinded, placebo-controlled, 2 x 2 factorial, randomised controlled trial - SELENIB, nested within a prospective observational cohort study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | BCPP - bladder cancer (superficial and invasive); SELENIB - superficial bladder cancer |
| Participants - inclusion criteria |
Inclusion criteria for SELENIB Trial:
1. Able to give informed consent for SELENIB 2. Previously registered onto the Bladder Cancer Prognosis Programme 3. Disease characteristics: histopathologically confirmed non-muscle invasive transitional cell carcinoma. Solitary grade 1 pTa larger than 3 cm and all other stage pTa, pT1 or pTcis |
| Participants - exclusion criteria |
Exclusion criteria for SELENIB trial:
1. Disease characteristics - solitary grade 1 pTa <3 cm or stage pT2 and above 2. Patients that are pregnant or breastfeeding 3. Patients diagnosed with human immunodeficiency virus (HIV) infection 4. Patients who are on immunosuppressive therapy following organ transplantion 5. Patients taking cyclosporin 6. Any condition, which, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives |
| Anticipated start date | 01/06/2006 |
| Anticipated end date | 01/06/2014 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at: http://www.bcpp.bham.ac.uk/PatientInfoSheets-v1.pdf |
| Target number of participants | 2700 (At time of registration: BCPP-3400 patients, of which 1200 patients randomised to SELENIB) |
| Interventions |
Patients are randomised to receive one of the following:
1. Selenium and vitamin E placebo 2. Selenium placebo and vitamin E (alpha-tocopherol) 3. Selenium and vitamin E (alpha-tocopherol) 4. Selenium placebo and vitamin E placebo |
| Primary outcome measure(s) |
SELENIB trial - primary outcomes
1. Recurrence-free interval 2. Progression-free interval Progression is defined as a recurrence with: 1. An increase in grade from grade 1/grade 2 to grade 3 2. An increase in tumour, node, metastasis (TNM) stage 3. The new occurrence of carcinoma in situ (CIS) in a bladder previously free from such lesions 4. The new occurrence of multiple urothelial tumours following resection of a solitary urothelial tumour 5. The need for a cystectomy because of refractory disease |
| Secondary outcome measure(s) |
SELENIB trial - secondary outcomes
1. All cause mortality 2. Incidence of transitional cell carcinoma (TCC) outside the bladder - we expect pathological confirmation will be available in most cases but a diagnosis based on strong clinical, radiological and cytological evidence will be acceptable 3. Incidence of all other malignancies clinically diagnosed - they may be pathologically confirmed or diagnosed based on strong clinical, radiological, laboratory marker or cytological evidence 4. Incidence of cardiovascular events: a. Myocardial infarction - the patient must have symptoms meeting World Health Organization (WHO) criteria and the event associated with abnormal levels of cardiac enzymes or diagnostic electrocardiograms (ECGs)b. Stroke - the patient must have a new neurological deficit of sudden onset that has persisted for more than 24 hours or until death within 24 hours c. Death from cardiovascular causes - this will be confirmed by autopsy reports, death certificates or medical records 5. Quality of life - as assessed by the quality of life instruments: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-BLS24 and QLQ-BLM30 |
| Sources of funding | Cancer Research UK (C1343/A5738) |
| Trial website | http://www.bcpp.bham.ac.uk |
| Publications | |
| Contact name | Prof K. K. Cheng |
| Address |
The Public Health Building
University of Birmingham Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Sponsor | University of Birmingham (United Kingdom) |
| Address |
Research and Enterprise Services
University of Birmingham Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Sponsor website: | http://www.bham.ac.uk |
| Date applied | 12/04/2006 |
| Last edited | 14/07/2011 |
| Date ISRCTN assigned | 24/05/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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