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Matrilysin Expression in Different Stages of Colorectal Tumors (MMP7)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Polistena MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01570452
First received: March 31, 2012
Last updated: April 3, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Cancer Stage 0
Colorectal Cancer Stage I
Colorectal Cancer Stage II
Colorectal Cancer Stage III
Colorectal Cancer Stage IV
 Procedure: colonic or colorectal resection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Matrilysin Expression in Different Stages of Colorectal Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Biospecimen Retention:   Samples With DNA

normal mucosa, cancer tissue, lymph nodes and serum from cancer patients serum from healty volunteers


Enrollment: 38
Study Start Date: September 2005
Study Completion Date: February 2012
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy volunteers
healthy subjects not affected by benign or malignant colonic disease
 Procedure: colonic or colorectal resection
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
 Procedure: colonic or colorectal resection
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
 Procedure: colonic or colorectal resection
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
 Procedure: colonic or colorectal resection
standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection

  Eligibility

Ages Eligible for Study:   40 Years to 83 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients affected by colorectal neoplasm admitted to our department of surgery

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570452

Locations
Italy
Departement of Surgery Pietro Valdoni
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Andrea Polistena, MD Department of Surgery Pietro Valdoni, University La Sapienza Rome
  More Information

Publications:

Responsible Party: Andrea Polistena MD, MD specialist in General Surgery, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01570452     History of Changes
Other Study ID Numbers: andreapolistena1
Study First Received: March 31, 2012
Last Updated: April 3, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
matrilysin
MMP-7
colorectal cancer
adenoma
lymph nodes

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013