To find procoagulant markers predictive of progression of the underlying malignancy or predictive of the occurrence of a venous thrombotic event.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study endpoint is the association between tissue factor positive
microparticles level in colorectal cancer patients and time to progression.
Secondary outcome
The association between other procoagulant markers (thrombomodulin, von
Willebrand factor, PAP-complex, PAI-1, P-selectin, thrombospondin 1, tissue
factor, cancer procoagulant, VEGF, thrombin generation, d-dimer) and time to
progression.
The association between procoagulant markers (tissue factor positive
microparticles, thrombomodulin, von Willebrand factor, PAP-complex, PAI-1,
P-selectin, thrombospondin 1, tissue factor positive microparticles, tissue
factor, cancer procoagulant, VEGF, thrombin generation, d-dimer) and the
occurrence of a VTE.
The association between procoagulant markers (tissue factor positive
microparticles, thrombomodulin, von Willebrand factor, PAP-complex, PAI-1,
P-selectin, thrombospondin 1, tissue factor positive microparticles, tissue
factor, cancer procoagulant, VEGF, thrombin generation, d-dimer) and disease
stage.
The association between procoagulant markers (tissue factor positive
microparticles, thrombomodulin, von Willebrand factor, PAP-complex, PAI-1,
P-selectin, thrombospondin 1, tissue factor positive microparticles, tissue
factor, cancer procoagulant, VEGF, thrombin generation, d-dimer) and the use of
chemotherapy.
The association between procoagulant markers (tissue factor positive
microparticles, thrombomodulin, von Willebrand factor, PAP-complex, PAI-1,
P-selectin, thrombospondin 1, tissue factor positive microparticles, tissue
factor, cancer procoagulant, VEGF, thrombin generation, d-dimer) and the use of
bevacizumab.
Background summary
There is an increased incidence of thrombosis in cancer patients. Thrombosis
leads to an increased morbidity, but can also lead to an increased mortality
(fatal pulmonary embolism). Besides the increased mortality due to a fatal
pulmonary embolism, cancer patients with thrombosis have a poorer prognosis
compared to cancer patients without thrombsis. The activated coagulation
cascade in patients with malignancy leads to tumor growth and angiogenesis.
Study objective
To find procoagulant markers predictive of progression of the underlying
malignancy or predictive of the occurrence of a venous thrombotic event.
Study design
multicentre prospective cohort study.
In colorectal cancer patients blood will be sampled combined with already
planned venous punctures.
Also tumor tissue removed at the planned operation will be examined.
Study burden and risks
There is no increased risk for the patient. There is hardly any burden for the
patient since the sampling of blood is already combined with planned venous
punctures. Therefore there is no need for extra venous punctures. Th
examination of the tumor tissue also does not lead to an increased burden,
since this tissue will be removed in an already planned operation.
P. Debeyelaan 25
6229 HX Maastricht
NL
P. Debeyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
colorectal cancer, any stage, not yet treated before
Exclusion criteria
second primary tumor, except basal cell carcinoma
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 |
|---|---|
| CCMO | NL27030.068.09 |
| Other | nummer volgt binnen 4 weken op trialregister.nl |