Mesalazine for the prevention of colorectal cancer: effects in patients with a history of sporadic adenomatous polyps

Conditions: sporadic colorectal adenomas
MedDRA version: 14.1Level: LLTClassification code 10069428Term: Colon adenomatous polypSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-001815-29-NL

Lead Sponsor: MC Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- having undergone complete colonoscopy with polypectomy, within 6 months of study entry, for removal of at least 2 colorectal adenomas, irrespective of size, and/or 1 colorectal adenoma with at least one of the following features: diameter of at least 1 cm, proximal localization, high-grade dysplasia or villous aspects.
- age 50-75 years

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

- inflammatory bowel disease
- familial colorectal cancer syndrome
- history of colorectal carcinoma
- history of surgery to the large bowel (except appendectomy)
- chronic renal insufficiency
- chronic hepatic insufficiency
- allergy to salicylates
- diabetes mellitus
- coagulation disorder or anticoagulant use, which cannot be temporarily discontinued
- asthma
- regular intake of one or more of the following immunosuppressants: thiopurines, methotrexate or cyclosporin
- prescription use of aspirin (high- and low-dose) and other NSAIDs

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Identify chemopreventive properties of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas by evaluating the effect of treatment on apoptosis and proliferation in histologically normal sigmoid and rectal mucosa relative to the placebo group.;Secondary Objective: Identify chemopreventive properties of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas by evaluating the effect of treatment on expression of ß-catenin signalling pathway components in histologically normal sigmoid and rectal mucosa relative to the placebo group.;Primary end point(s): The effect of treatment with mesalazine on apoptotic and proliferation indices relative to the placebo group. ;Timepoint(s) of evaluation of this end point: before treatment and after 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The effect of treatment with mesalazine on the expression of beta-catenin signalling pathway components relative to the placebo group.;Timepoint(s) of evaluation of this end point: before treatment and after 6 months of treatment