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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01570452
Other study ID # andreapolistena1
Secondary ID
Status Completed
Phase N/A
First received March 31, 2012
Last updated April 3, 2012
Start date September 2005
Est. completion date February 2012

Study information

Verified date March 2012
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date February 2012
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 83 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Procedure:
colonic or colorectal resection
standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection

Locations

Country Name City State
Italy Departement of Surgery Pietro Valdoni Rome

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

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