The role of microparticles bearing active tissue factor in cancer and thrombosis: "The Bouillaud Study"

The role of microparticles bearing active tissue factor in cancer and
thrombosis: "The Bouillaud study"

The incidence of cancer is growing with increased ageing of people and cancer
is now the leading cause of death in the West European countries and the US.
Hypercoagulability seems to contribute to the two most frequent causes of death
in cancer patients, namely metastases and venous thrombosis. The poor prognosis
of cancer patients who develop thrombosis forms a challenge to clinicians to
select cancer patients at highest risk for development of thrombosis and to
develop effective prophylactic strategies to prevent thrombosis and hopefully
also improve survival.

Although the relationship between cancer and thrombosis has been known for more
than a century, the mechanism by which tumour predispose to thrombosis has not
been elucidated. The activation of blood coagulation in patients with cancer
may well have several causes. Prothrombotic mechanisms may be related to the
host's response to cancer and other factors to procoagulant properties of the
cancer cells themselves.

The aim of this prospective cohort study is to investigate the role of MP-TF
activity and MP phenotypes in specific types of malignancies and to assess if
it are predictive markers for the development of thrombosis, progression of the
malignant disease and survival.

Primary objectives
In all patients included in the study
To asses whether:
- MP-TF activity and MP phenotype is associated with specific types of
malignancy.
- MP-TF activity and MP phenotype predicts for development of thrombosis.
- MP-TF activity and MP phenotype predicts for an unfavorable course of the
disease (progression).

In patients who develop thrombosis or embolism
To assess whether:
- MP-TF activity is elevated at the time of clinically manifest and
radiologically confirmed venous thromboembolism and whether MP-TF activity
levels change after a period of 1-2 months of effective anticoagulation.

In patients who undergo a change in the stage of their disease
To assess whether:
- MP-TF activity is elevated at the time of a significant change in stage of
the disease (progression).

Secundary objectives
To investigate:
- MP-TF activity and phenotype in healthy subjects to assess the levels an
standard deviation in healthy controls.
- Other possibly relevant factors such as circulating levels of P-selectin and
tissue factor as well as Factor V Leiden and prothrombin mutation, the two
major risk factors for development of thrombosis in the normal population.

Prospective cohort study

Patients:
- One questionaire at the start of the study.
- Patients will be contacted every 3 months by the dedicated research nurses to
get information about the clinical course of their disease and with regard to
occurrence of thrombosis.

Blood collection (30ml blood) at the following moments;
1) at start from the study (all patients)
2) in case of thrombosis (within 24hr or max. 48h after diagnoses) preferably
before the start of anticoagulation therapy.
3) 1-2 months after the occurence of thrombosis.
4) at the time of a change in the stage of the disease (progression) and in any
case before the start of any systemic anti-cancer treatment.

The total times of blood collection will thus differ per patient. It will
depent of the times and onset of each moment.
We will try to make it as less invasive as possible for the patient by planning
the blood collection at the time of routine laboratory controls or when ít is
suitable for the patient .