Condition category
Cancer
Date applied
12/04/2006
Date assigned
24/05/2006
Last edited
18/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof K. K. Cheng

ORCID ID

Contact details

The Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00553215

Protocol/serial number

BCPP 2005-01

Study information

Scientific title

Bladder Cancer Prognosis Programme (incorporating SELENIB trial)

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

Nottingham Research Ethics Committee (REC) 2, October 2005, ref: 05/Q2404/173

Study design

Double-blinded placebo-controlled 2 x 2 factorial randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Patient information can be found at: http://www.bcpp.bham.ac.uk/PatientInfoSheets-v1.pdf

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

Phase

Not Specified

Drug names

Selenium, vitamin E (aplha-tocopherol

Primary outcome measures

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 trial start date

01/06/2006

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

2700 (At time of registration: BCPP-3400 patients, of which 1200 patients randomised to SELENIB)

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

United Kingdom

Trial participating centre

The Public Health Building
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (United Kingdom)

Sponsor details

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

Sponsor type

University/education

Website

http://www.bham.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (C1343/A5738)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.