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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-06-30

Brief Summary

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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. .

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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5-ASA

Mesalazine 800 mg orally t.i.d for 3 months

Group Type EXPERIMENTAL

Mesalazine

Intervention Type DRUG

Mesalazine cpr 800 mg t.i.d. for 3 months

No treatment

no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mesalazine

Mesalazine cpr 800 mg t.i.d. for 3 months

Intervention Type DRUG

Other Intervention Names

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5-aminosalicylic acid 5-ASA Pentacol

Eligibility Criteria

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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

\- 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No