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

Colorectal Cancer Clinical Trial

— COMET  

Official title:

Role of the MET Oncogene in Human Colorectal Cancer. Possible Implications in the Activation of an Acquired Pro-thrombotic Condition - A Translational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238821
• Other study ID #: MET/colon 06
• Status: Completed
• Phase: N/A
• First received: September 1, 2014
• Last updated: March 2, 2017
• Start date: October 2007
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia	Candiolo	TO

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scoring MET expression in colorectal tissue sections by immunohistochemical analysis		After surgical resection of the tumor, approximately 3-5 days after enrollement
Primary	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
Primary	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