Role of the MET Oncogene in Human Colorectal Cancer - A Translational Study

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT02238821
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Brief Summary

The MET oncogene is known to sustain the Trousseau's syndrome in murine experimental models, featuring association of carcinogenesis with a blood procoagulant disorder. MET is frequently overexpressed in colorectal cancer, a tumor where venous thromboembolism (VTE) may occur in association with poor prognosis, but the biological and genetic factors that cause VTE are still obscure.

The Investigators propose to study whether in patients harboring a surgically resectable colorectal cancer the MET oncogene is expressed and may be associated with a blood thrombophilic condition that favors the onset of VTE.

These data would have two main implications: (i) for the first time, a direct genetic link between the MET oncogene and a procoagulant disorder would be demonstrated in humans; (ii) the procoagulant alterations would have diagnostic/prognostic significance for the identification of patients at risk for poor outcome, and implementation of appropriate therapeutic protocols.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-12
• Status Verified: 2016-08
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age > or = 18;
• age < or = 80;
• Clinical diagnosis of colorectal tumor by CT, MRI or endoscopy;
• surgically resectable tumor;

Exclusion Criteria

• Inclusion in other clinical protocols requiring administration of anticoagulant drugs;
• Life expectancy < 6 month;
• Clinical diagnosis of thrombophilic condition by laboratory analysis;
• Previously implanted Central Venous Catheter;
• Previous or concomitant second neoplasia;
• Clinical diagnosis of kidney, liver or heart failure;
• Inflammatory markers alteration associated with disease unrelated to neoplasia (infection, connective tissue disease etc);
• Severe hemostasis disorder;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scoring MET expression in colorectal tissue sections by immunohistochemical analysis	After surgical resection of the tumor, approximately 3-5 days after enrollement
Scoring the expression of Plasminogen Activator Inhibitor -1 in colorectal cancer tissue sections by Immunohistochemical analysis	After surgical resection of the tumor, approximately 3-5 days after enrollement
Scoring the expression of COX-2 in colorectal cancer tissue sections by Immunohistochemical analysis	After surgical resection of the tumor, approximately 3-5 days after enrollement

Trial Locations

Locations (1)

Fondazione del Piemonte per l'Oncologia; 🇮🇹 Candiolo, TO, Italy