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) | |
| Study type | |
| 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 | All |
| 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, Cancer Research UK (CRUK), CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |