Chemopreventive Action of Mesalazine on Colorectal Cancer: a Pilot Study for an "in Vivo" Evaluation of the Molecular Effects on β-catenin Signaling Pathway.

Azione Chemiopreventiva Della Mesalazina Sul Cancro Del Colon-retto: Studio Pilota Per la Valutazione Degli Effetti Molecolari "in Vivo" Sulla Via di Segnalazione Proliferativa Della β-catenina (Official Title in Italian Language)

The purpose of this study is to obtain an "in vivo" confirmation that mesalazine induces the gene expression of μ-protocadherin and other related genes in the colon mucosa, as demonstrated in some "in vitro" experiments. .

Pilot Trial, single-blind, parallel group on biopsy specimens of healthy colon mucosa in patients with precancerous lesions of the colon and rectum (adenomas) treated with mesalazine.

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