Concerted Action Polyp Prevention

ISRCTN	ISRCTN83743312
DOI	https://doi.org/10.1186/ISRCTN83743312
Protocol serial number	1
Sponsor	Newcastle upon Tyne Hospitals NHS Trust (UK)
Funders	European Union Biomedical and Health Research - Biomed 1 Programme, Bayer Corporation (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof John Burn
Scientific

Institute of Human Genetics
Centre for Life
Central Parkway
Newcastle upon Tyne
NE1 3BZ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Aspirin, resistant starch
Primary outcome measure(s)	1. Age at colectomy 2. Reduction in size of polyps 3. Changes in crypt cell proliferation
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

Institute of Human Genetics

Newcastle upon Tyne
NE1 3BZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011		Yes	No
Protocol article	protocol	01/07/1995		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes