Matrilysin Expression in Different Stages of Colorectal Tumors (MMP7)

April 3, 2012 updated by: Andrea Polistena MD, University of Roma La Sapienza

Matrix metalloproteinases (MMPs) have been shown to be involved in cancer biology. Significant expression of MMP-7 (matrilysin) in colorectal cancer is mainly associated with metastatic disease even though it is expressed in most tumor states. Our purpose is to analyse MMP-7 in bowel and lymph nodes of different tumor stages and to evaluate its expression as a potential biomarker of cancer disease in patients surgically treated for benign and malignant colorectal tumors. Tumoral tissue, lymph nodes and serum samples from recruited Patients plus serum samples from healthy volunteers are analysed for matrilysin expression by histology, immunohistochemistry, ELISA and Western blotting.

If Matrilysin increases with increasing dysplasia and cancer disease stage in tumor tissue as well as in the regional lymph nodes it might be used as a complement in investigating suspected locally advanced cancer.

Study Overview

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rome, Italy, 00161
        • Departement of Surgery Pietro Valdoni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients affected by colorectal neoplasm admitted to our department of surgery

Description

Inclusion Criteria:

  • benign colonic neoplasm not suitable for endoscopic treatment,
  • malignant colonic neoplasm with indication to primary surgical treatment

Exclusion Criteria:

  • neo-adjuvant radiotherapy,
  • chemo-radiotherapy,
  • language problems and withdrawal of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy volunteers
healthy subjects not affected by benign or malignant colonic disease
standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection
benign colonic tumor patients
patients affected by benign colonic tumor such as adenoma
standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection
cancer patient I-II stage
Patients affected by colonic cancer in I-II stage
standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection
cancer patients III-IV stage
Patients affected by colonic cancer in III-IV stage
standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrea Polistena, MD, Department of Surgery Pietro Valdoni, University La Sapienza Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 31, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

March 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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