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Coagulation in Colorectal cancer.


- candidate number5642
- NTR NumberNTR1773
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-apr-2009
- Secondary IDs09-2-033 METC MUMC
- Public TitleCoagulation in Colorectal cancer.
- Scientific TitleCoagulation in Colorectal cancer.
- ACRONYMthe CoCo study
- hypothesisCancer patients who develop thrombosis have a worse prognosis than cancer patinets without thrombosis. There is evidence that activation of the coagulation cascade increases tumor growth and angiogenesis. Therefore the objective is to find a marker in blood linked to angiogenesis and coagulation to predict the prognosis in cancer patients.
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Thrombosis
- Inclusion criteria1. Patients newly diagnosed with colorectal cancer who have not yet been treated;
2. Any disease stage;
3. Age 18 years or older.
- Exclusion criteria1. Second primary tumor in the past 5 years, except basal cell carcinoma and in situ carcinomas;
2. Not able to give written informed consent.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2009
- planned closingdate30-sep-2012
- Target number of participants300
- InterventionsN/A, observational study.
- Primary outcomePrimary Objective: the association between tissue factor positive microparticles level in colorectal cancer patients and time to progressive disease.
- Secondary outcomeSecondary Objectives:
1. The association between the other chosen markers (thrombomodulin, vWf, tissue factor, cancer procoagulant, thrombin generation, PAP-complex, PAI-1, d-dimer, P-selectin, VEGF, Thrombospondi1, CRP) and time to progressive disease; 2. The association between the chosen markers and the occurrence of a VTE;
3. The association between the chosen markers and disease stage;
4. The association between the chosen markers and the use of chemotherapy;
5. The association between the chosen markers and the use of bevacizumab.
- TimepointsBlood will be sampled at specific points in treatment and in case of progressive disease and thrombosis. Patients will be followed two years.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. J.H.M.J. Vestjens
- CONTACT for SCIENTIFIC QUERIESDrs. J.H.M.J. Vestjens
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryRationale:
Cancer patients who develop a venous thrombotic event have a worse prognosis compared to patients without thrombosis. There is evidence that activation of the coagulation cascade increases tumor growth and angiogenesis.
Objective:
To find a marker linked to angiogenesis and coagulation to predict prognosis in cancer patients.
Study design:
Multicenter prospective cohort study.
Study population:
colorectal cancer patients, all disease stages.
Main study parameters/endpoints:
Primary Objective: the association between tissue factor positive microparticles level in colorectal cancer patients and time to progressive disease.
Secondary Objectives:
1. The association between the other chosen markers ( thrombomodulin, von Willebrand factor, VEGF, Tissue factor, cancer procoagulant, thrombin generation, PAI-1, PAP complex, CRP, d-dimer, P-selectin, thrombospondin-1) and time to progressive disease;
2. The association between the chosen markers and the occurrence of a VTE;
3. The association between the chosen markers and disease stage;
4. The association between the chosen markers and the use of chemotherapy;
5. The association between the chosen markers and the use of bevacizumab.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
In colorectal cancer patients extra blood will be sampled. In every venous puncture 25 ml extra blood will be sampled. There is no need for extra visits or patient questionnaires. Therefore there is no extra risk expected with a minimum of burden. Also already excised tumor tissue will be examined. Extra blood sampling will occur depending on treatment schedule for a minimum of two times to a maximum of six times.
- Main changes (audit trail)
- RECORD22-apr-2009 - 23-sep-2009


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