colorectal adenoma (polyp) MedDRA version: 14.1 Level: LLT Classification code 10048841 Term: Bowel cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Aspirin protect 300 mg
Product Name: Aspirin
Pharmaceutical Form: Tablet
CAS Number: 50-78-2
Other descriptive name: ASPIRIN
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Recruitment will be restricted to 60-73 year-old NHS Bowel Cancer Screening Programme (BCSP) patients who have been identified as ‘high risk’ (5 or more small adenomas or 3 or more adenomas with at least one being greater or equal to 10 mm in diameter) after a single clearance screening colonoscopy. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Requires more than one repeat colonoscopy or flexible sigmoidoscopy within the BCSP 3 month screening window • Regular (>3 doses per week) prescribed aspirin or regular (>3 doses per week) prescribed non-aspirin non-steroidal anti-inflammatory drug (NSAID) use • Aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma • Active peptic ulcer disease within 3 months or previous peptic ulcer (not on proton pump inhibitor prophylaxis) • Fish or seafood allergy • Current or planned regular (>3 doses per week) use of fish oil supplements • Known clinical diagnosis or gene carrier of a hereditary colorectal cancer (CRC) predisposition (familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC)) • Previous or newly diagnosed inflammatory bowel disease • Previous or planned colorectal resection • Known bleeding diathesis or concomitant warfarin therapy or use of any other anti-coagulant or anti-platelet agent (eg. Clopidogrel) • Severe renal failure (creatinine clearance <10 ml/min) • Current methotrexate use at a weekly dose of 15 mg or more • Inability to comply with study procedures and agents • Serious medical illness interfering with study participation • Participant taking part in another interventional clinical trial • Failure to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the naturally-occurring omega (?)-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) prevents colorectal adenomas, either alone or in combination with aspirin.;Secondary Objective: To assess the tolerability and safety of EPA in the free fatty acid form (EPA-FFA) alone, and in combination with aspirin, in elderly (60-75 years) subjects. The aims of the laboratory studies linked to the seAFOod Polyp Prevention Trial are: 1. to gain understanding of the mechanism(s) of the chemopreventative activity of EPA-FFA and aspirin, alone and in combination. 2. to identify a lipid substance(s) (known as a biomarker) which predicts response to chemoprevention therapy. 3. to identify a predictive biomarker(s) of chemopreventative efficacy of EPA and aspirin in index colorectal adenoma tissue obtained at screening colonoscopy. 4. To understand how differences in patient genotype predict the chemopreventative efficacy of EPA and aspirin, alone and in combination;Primary end point(s): The number of ‘high risk’ participants with one or more adenomas detected at the first BCSP surveillance colonoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The number of participants with one or more ‘advanced’ (=10 mm diameter, high-grade dysplasia or tubulo-villous/villous histology) adenomas at one year 2. The number of ‘advanced’ adenomas per participant at BCSP surveillance colonoscopy at one year 3. The total number of adenomas per participant at BCSP surveillance colonoscopy at one year 4. The region of the colorectum (right colon - any part of the colon proximal to the splenic flexure; left colon – the rectum and the colon distal to the splenic flexure) that adenomas are detected at BCSP surveillance colonoscopy at one year 5. The number of ‘high risk’ participants re-classified as ‘intermediate risk’ after BCSP surveillance colonoscopy at one year (BCSP risk stratification at one year surveillance colonoscopy follows BSG Guidelines35 so that any individual that does not continue to fulfil ‘high risk’ criteria is classified as ‘intermediate risk’ for further colonoscopic surveillance at three years) 6. Adverse events, including clinically significant bleeding episodes | — |
Countries
United Kingdom
Outcome results
None listed