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

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ClinicalTrials.gov Identifier: NCT02077777
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
SOFAR S.p.A.

Brief Summary:
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. .

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Mesalazine Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5-ASA
Mesalazine 800 mg orally t.i.d for 3 months
Drug: Mesalazine
Mesalazine cpr 800 mg t.i.d. for 3 months
Other Names:
  • 5-aminosalicylic acid
  • 5-ASA
  • Pentacol

No Intervention: No treatment
no treatment



Primary Outcome Measures :
  1. Molecular analysis of gene expression levels of μ-protocadherin and other related proteins [ Time Frame: 3 months ]
    Molecular analysis (quantitative RT-PCR) of gene expression levels of μ-protocadherin, protocadherin 19, protocadherin 24, cadherin E, TCF7L2, TCF4, c-myc, Cyclin D1, p21waf1, VEGF, CD44, Met, KLF4 e CEBP-α and comparison of the levels assessed at the end of the treatment period with the baseline.


Secondary Outcome Measures :
  1. Evaluation of protein expression level of μ-protocadherin, Ki-67, Caspase-3 and Histone H2AXγ, evaluation of DNA oxidative damage and intra-mucosal concentration of 5-Acetylsalicylic acid [ Time Frame: 3 months ]

    These parameters will be examined using molecular analysis of the oxidation and depurination levels of the DNA and chromatographic analysis of the intra-mucosal concentration of 5-Acetylsalicylic acid, in biopsies of normal mucosa of the colon taken before and after the treatment of patients with 5-Acetylsalicylic acid:

    • quantification of the percentage of cells expressing the following proteins by immunohistochemical analysis: μ-protocadherin, Ki-67, Caspase-3 and Histone H2AXγ;
    • quantification of number of AP sites per 100000 DNA bp
    • quantification of nanograms di 8-OhdG (8-hydroxyguanine) per micrograms of DNA



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077777


Locations
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Italy
Istituti Ospitalieri di Cremona
Cremona, Italy, 26100
Sponsors and Collaborators
SOFAR S.p.A.
Investigators
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Principal Investigator: Federico Buffoli, Doctor Istituti Ospitalieri di Cremona

Publications:

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Responsible Party: SOFAR S.p.A.
ClinicalTrials.gov Identifier: NCT02077777     History of Changes
Other Study ID Numbers: MES-CT 01
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by SOFAR S.p.A.:
mesalazine
colon
cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Aminosalicylic Acid
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents