A randomised double-blind placebo-controlled cancer prevention trial with an estimated duration of 5 years and with 52,000 subjects recruited from the general populations of the UK, Denmark, Sweden, Finland and the United States
ISRCTN | ISRCTN64336220 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN64336220 |
Secondary identifying numbers | PRECISE |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 15/11/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised double-blind placebo-controlled |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Not provided at time of registration Added as of 27/03/2009: Please note that this trial never started due to lack of funding. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Multiple cancer sites |
Intervention | Four treatment groups: 1. Placebo 2. 100 micrograms selenium/day 3. 200 micrograms selenium/day 4. 300 micrograms selenium/day |
Intervention type | Other |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1995 |
Completion date | 29/06/2001 |
Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 52,000 |
Key inclusion criteria | All those aged between 60 and 74 years are eligible. |
Key exclusion criteria | 1. Southwest Oncology Group (SWOG) performance status score of greater then 1 or equivalent 2. Active liver or kidney disease 3. Prior diagnosis of cancer 4. Diagnosed Human Immunodeficiency Virus (HIV) infection 5. Disminished mental capacity 6. Taking 50 micrograms/day or more of selenium supplements |
Date of first enrolment | 01/01/1995 |
Date of final enrolment | 29/06/2001 |
Locations
Countries of recruitment
- Denmark
- England
- Finland
- Sweden
- United Kingdom
- United States of America
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Phone | +44 (0)207 317 5186 |
---|---|
kate.law@cancer.org.uk | |
Website | http://www.cancer.org.uk |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
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 | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |