Colorectal CancerCOMETNCT02238821
Role of the MET Oncogene in Human Colorectal Cancer - A Translational Study
An observational study of Colorectal Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with resectable colorectal tumor with survival prognosis>6 month
Who may be able to join
- age > or = 18;
- age < or = 80;
- Clinical diagnosis of colorectal tumor by CT, MRI or endoscopy;
- surgically resectable tumor;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| resectable colorectal cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring MET expression in colorectal tissue sections by immunohistochemical analysis
Measured: 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
Measured: 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
Measured: After surgical resection of the tumor, approximately 3-5 days after enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2007
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo M Comoglio, MD, Study director, Fondazione del Piemonte per l'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238821
- Sponsor's protocol ID
- MET/colon 06
- Acronym
- COMET
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02238821
- Acronym / sponsor ID
- COMET / MET/colon 06
- Conditions
- Colorectal Cancer
- Keywords
- resectable colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| resectable colorectal cancer | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resectable colorectal tumor with survival prognosis>6 month
Key inclusion criteria (4 listed)
- age > or = 18;
- age < or = 80;
- Clinical diagnosis of colorectal tumor by CT, MRI or endoscopy;
- surgically resectable tumor;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scoring MET expression in colorectal tissue sections by immunohistochemical analysis
Time frame: 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
Time frame: 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
Time frame: After surgical resection of the tumor, approximately 3-5 days after enrollement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo M Comoglio, MD study director
Fondazione del Piemonte per l'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring MET expression in colorectal tissue sections by immunohistochemical analysis (time frame: After surgical resection of the tumor, approximately 3-5 days after enrollement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.