Concerted Action Polyp Prevention
| ISRCTN | ISRCTN83743312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83743312 |
| Secondary identifying numbers | 1 |
- Submission date
- 18/08/2005
- Registration date
- 15/09/2005
- Last edited
- 25/09/2012
- 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 of protocol
Not provided at time of registration
Contact information
Prof John Burn
Scientific
Scientific
Institute of Human Genetics
Centre for Life
Central Parkway
Newcastle upon Tyne
NE1 3BZ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | CAPP1 |
| Study objectives | Daily use of aspirin and resistant starch will reduce the risk of polyp formation and of subsequent colon cancer. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Familial Adenomatous Polyposis (FAP) |
| Intervention | Factorial design of: A. 600 mg Aspirin and 30 g Resistant Starch B. Placebo Aspirin and 30 g Resistant Starch C. 600 mg Aspirin and 30 g Placebo Starch D. Placebo Aspirin and Placebo Starch |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aspirin, resistant starch |
| Primary outcome measure | 1. Age at colectomy 2. Reduction in size of polyps 3. Changes in crypt cell proliferation |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1993 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Known carriers of familial adenomatous polyposis (FAP), either by molecular genetic analysis or by phenotypic features 2. Over 10 years of age with an intact colon |
| Key exclusion criteria | 1. Already taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 2. Partial Resection 3. If over 21 years of age - to take treatment for 1 year only |
| Date of first enrolment | 01/01/1993 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Human Genetics
Newcastle upon Tyne
NE1 3BZ
United Kingdom
NE1 3BZ
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R and D Department
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Industry
European Union Biomedical and Health Research - Biomed 1 Programme
No information available
Bayer Corporation (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/1995 | Yes | No | |
| Results article | results | 01/05/2011 | Yes | No |
