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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

March 31, 2012
April 3, 2012
September 2005
September 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01570452 on ClinicalTrials.gov Archive Site
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Matrilysin Expression in Different Stages of Colorectal Tumors
Matrilysin Expression in Different Stages of Colorectal Tumors

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

normal mucosa, cancer tissue, lymph nodes and serum from cancer patients serum from healty volunteers
Non-Probability Sample

patients affected by colorectal neoplasm admitted to our department of surgery
  • 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
standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection
  • healthy volunteers
    healthy subjects not affected by benign or malignant colonic disease
    Intervention: Procedure: colonic or colorectal resection
  • benign colonic tumor patients
    patients affected by benign colonic tumor such as adenoma
    Intervention: Procedure: colonic or colorectal resection
  • cancer patient I-II stage
    Patients affected by colonic cancer in I-II stage
    Intervention: Procedure: colonic or colorectal resection
  • cancer patients III-IV stage
    Patients affected by colonic cancer in III-IV stage
    Intervention: Procedure: colonic or colorectal resection
Mori M, Barnard GF, Mimori K, Ueo H, Akiyoshi T, Sugimachi K. Overexpression of matrix metalloproteinase-7 mRNA in human colon carcinomas. Cancer. 1995 Mar 15;75(6 Suppl):1516-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
February 2012
September 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 83 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01570452
andreapolistena1
No
Andrea Polistena MD, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Principal Investigator: Andrea Polistena, MD Department of Surgery Pietro Valdoni, University La Sapienza Rome
University of Roma La Sapienza
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP