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

NCT02238821 | Completed

• 1 other identifier: MET/colon 06
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

resectable colorectal cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

resectable colorectal cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with resectable colorectal tumor with survival prognosis\>6 month

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Fondazione del Piemonte per l'Oncologia

Candiolo, TO, 10060, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Paolo M Comoglio, MD

  Fondazione del Piemonte per l'Oncologia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 12, 2014
• Study Start: October 1, 2007
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2016-08

Locations

IT (1)