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OpenTrials
Completed

NCT Number: NCT02238821

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione del Piemonte per l'Oncologia

Candiolo, TO, 10060, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Scoring MET expression in colorectal tissue sections by immunohistochemical analysis

    Time frame: After surgical resection of the tumor, approximately 3-5 days after enrollement

  2. Scoring the expression of Plasminogen Activator Inhibitor -1 in colorectal cancer tissue sections by Immunohistochemical analysis

    Time frame: After surgical resection of the tumor, approximately 3-5 days after enrollement

  3. Scoring the expression of COX-2 in colorectal cancer tissue sections by Immunohistochemical analysis

    Time frame: After surgical resection of the tumor, approximately 3-5 days after enrollement

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study title

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

Acronym: COMET

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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