NCT01570452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
Last Updated

April 4, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

March 31, 2012

Last Update Submit

April 3, 2012

Conditions

Keywords

matrilysinMMP-7colorectal canceradenomalymph nodes

Study Arms (4)

healthy volunteers

healthy subjects not affected by benign or malignant colonic disease

Procedure: colonic or colorectal resection

benign colonic tumor patients

patients affected by benign colonic tumor such as adenoma

Procedure: colonic or colorectal resection

cancer patient I-II stage

Patients affected by colonic cancer in I-II stage

Procedure: colonic or colorectal resection

cancer patients III-IV stage

Patients affected by colonic cancer in III-IV stage

Procedure: colonic or colorectal resection

Interventions

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

benign colonic tumor patientscancer patient I-II stagecancer patients III-IV stagehealthy volunteers

Eligibility Criteria

Age40 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients affected by colorectal neoplasm admitted to our department of surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Surgery Pietro Valdoni

Rome, 00161, Italy

Location

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

    PMID: 7889484BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Colorectal NeoplasmsAdenoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Andrea Polistena, MD

    Department of Surgery Pietro Valdoni, University La Sapienza Rome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD specialist in General Surgery

Study Record Dates

First Submitted

March 31, 2012

First Posted

April 4, 2012

Study Start

September 1, 2005

Primary Completion

September 1, 2008

Study Completion

February 1, 2012

Last Updated

April 4, 2012

Record last verified: 2012-03

Locations