Bladder Cancer Prognosis Programme (incorporating SELENIB trial)

ISRCTN	ISRCTN13889738
DOI	https://doi.org/10.1186/ISRCTN13889738
ClinicalTrials.gov number	NCT00553215
Secondary identifying numbers	BCPP 2005-01

Submission date: 12/04/2006
Registration date: 24/05/2006
Last edited: 02/11/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-risk-factors-for-bladder-cancer-coming-back

Study website

Contact information

Prof Richard Bryan
Principal Investigator

Institute of Cancer and Genomic Sciences
Robert Aitken Institute for Clinical Research
College of Medical and Dental Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

ORCID ID	0000-0003-2853-4293
Phone	+44 (0)121 414 7870
Email	r.t.bryan@bham.ac.uk

Prof Richard Bryan
Scientific

Institute of Cancer and Genomic Sciences
Robert Aitken Institute for Clinical Research
College of Medical and Dental Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 7870
Email	r.t.bryan@bham.ac.uk

Mr Ben Abbotts
Public

BCPP/SELENIB Trial Coordinator
POUT-T Trial Coordinator
Institute of Cancer and Genomic Sciences
Room G26, RAICR
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 415 8836
Email	b.abbotts@bham.ac.uk

Study information

Study design	Double-blinded placebo-controlled 2 x 2 factorial randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	http://www.bcpp.bham.ac.uk/PatientInfoSheets-v1.pdf
Scientific title	Bladder Cancer Prognosis Programme (incorporating SELENIB trial)
Study acronym	BCPP, SELENIB
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
Ethics approval(s)	Nottingham Research Ethics Committee (REC) 2, October 2005, ref: 05/Q2404/173
Condition	BCPP - bladder cancer (superficial and invasive); SELENIB - superficial bladder cancer
Intervention	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
Intervention type	Supplement
Primary outcome measure	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 measures	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
Overall study start date	01/06/2006
Overall study end date	01/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	2700 (At time of registration: BCPP-3400 patients, of which 1200 patients randomised to SELENIB)
Total final enrolment	270
Participant 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
Participant 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
Recruitment start date	01/06/2006
Recruitment end date	01/06/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Public Health Building

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (United Kingdom)
University/education

Research and Enterprise Services
University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website	http://www.bham.ac.uk
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Charity

Cancer Research UK (C1343/A5738)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date	22/08/2023
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Current publication and dissemination plan as of 23/03/2023: Planned publication in a high-impact peer-reviewed journal Previous publication and dissemination plan: Not provided at time of registration
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results	BCPP			No	Yes
Results article		02/10/2023	23/10/2023	Yes	No
Plain English results	SELENIB		02/11/2023	No	Yes

Editorial Notes

02/11/2023: Cancer Research UK plain English results link added.
23/10/2023: Publication reference and total final enrolment added.
30/03/2023: The study contacts were updated.
23/03/2023: The following changes have been made to the study record:
1. The publication and dissemination plan has been changed.
2. The individual participant data (IPD) sharing statement and summary have been added.
3. The intention to publish date has been changed from 31/12/2019 to 22/08/2023.
30/01/2019: Intention to publish date added
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.
15/02/2011: The target participant number has been updated from 3400 to 2700.