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This pilot study evaluates whether Mesalazine may help prevent colorectal cancer by studying its molecular effects on the β-catenin signaling pathway. Patients with precancerous colorectal lesions (polyps or adenomas) who needed a follow-up endoscopy after removal were able to take part. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients with precancerous colorectal lesions (polypoid or nonpolypoid adenomas) that needs of an endoscopic exam of control after 3 months from the removal of the lesions (determined on the basis of the morphological and histological characteristics of the lesions and of the removal technique) * Ability and willingness to adhere to study regimen * Written informed consent The following inclusion criteria was deleted according to Amendment n. 01 approved by the Ethical Committee on 19/dec/2014: \- diverticular disease/diverticular colitis; The rationale of this change is that the presence of diverticular disease/diverticular colitis does not contribute to the definition of the trial primary end-points and represents a critical point during the patient selection with an impact on duration and conduction of the study. Exclusion Criteria: * Patients under therapy with Aspirin (\>100 mg/die) or other FANS * Inflammatory bowel disease (IBD) * Hypersensitivity to Mesalazine. * Pregnant or nursing (lactating) women * Patients who belonging to the category n. 4 of the ASA physical status classification system * contraindications to mesalazine therapy