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

SOFAR

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Mesalazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02077777

MES-CT 01

Details and patient eligibility

About

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. .

Full description

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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