No registrations found.
ID
Source
Brief title
Health condition
colorectal cancer, colorectaal carcinoom, coagulation, stolling, angiogenesis, angiogenese, thrombosis, trombose, prognosis, prognose
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: the association between tissue factor positive microparticles level in colorectal cancer patients and time to progressive disease.
Secondary outcome
Secondary 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.
Background summary
Rationale:
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.
Study objective
Cancer 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.
Study design
Blood will be sampled at specific points in treatment and in case of progressive disease and thrombosis. Patients will be followed two years.
Intervention
N/A, observational study.
P.O.Box 5800
J.H.M.J. Vestjens
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3877025
h.vestjens@mumc.nl
P.O.Box 5800
J.H.M.J. Vestjens
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3877025
h.vestjens@mumc.nl
Inclusion criteria
1. Patients newly diagnosed with colorectal cancer who have not yet been treated;
2. Any disease stage;
3. Age 18 years or older.
Exclusion criteria
1. Second primary tumor in the past 5 years, except basal cell carcinoma and in situ carcinomas;
2. Not able to give written informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1672 |
| NTR-old | NTR1773 |
| Other | METC MUMC : 09-2-033 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |