Clinical trial NCT02238821: Role of the MET Oncogene in Human Colorectal Cancer - A Translational Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: resectable colorectal cancer
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with resectable colorectal tumor with survival prognosis\>6 month

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Scoring MET expression in colorectal tissue sections by immunohistochemical analysis
timeFrame: After surgical resection of the tumor, approximately 3-5 days after enrollement
measure: Scoring the expression of Plasminogen Activator Inhibitor -1 in colorectal cancer tissue sections by Immunohistochemical analysis
timeFrame: After surgical resection of the tumor, approximately 3-5 days after enrollement
measure: Scoring the expression of COX-2 in colorectal cancer tissue sections by Immunohistochemical analysis
timeFrame: After surgical resection of the tumor, approximately 3-5 days after enrollement
Secondary outcomes:
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia
state: TO
Study officials:
affiliation: Fondazione del Piemonte per l'Oncologia
name: Paolo M Comoglio, MD
role: STUDY_DIRECTOR
References: