Matrilysin Expression in Different Stages of Colorectal Tumors

NCT ID: NCT01570452

Last Updated: 2012-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-02-29

Brief 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.

Conditions

Colorectal Cancer Stage 0; Colorectal Cancer Stage I; Colorectal Cancer Stage II; Colorectal Cancer Stage III; Colorectal Cancer Stage IV

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy volunteers

healthy subjects not affected by benign or malignant colonic disease

colonic or colorectal resection

Intervention Type: PROCEDURE

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

colonic or colorectal resection

Intervention Type: PROCEDURE

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

colonic or colorectal resection

Intervention Type: PROCEDURE

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

colonic or colorectal resection

Intervention Type: PROCEDURE

standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection

Interventions

colonic or colorectal resection

standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 83 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Andrea Polistena MD

MD specialist in General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Polistena, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery Pietro Valdoni, University La Sapienza Rome

Locations

Departement of Surgery Pietro Valdoni

Rome, , Italy

Countries

Italy

References

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. doi: 10.1002/1097-0142(19950315)75:6+3.0.co;2-7.

Reference Type: BACKGROUND

PMID: 7889484 (View on PubMed)

Other Identifiers

andreapolistena1

Identifier Type: -

Identifier Source: org_study_id