Thrombosis Embolism, Thromboses, Venous, Cancer
Conditions
Brief summary
Venous thromboembolic disease (VTE) is a common (1/1000), potentially serious disease (10% mortality when the clinical presentation is that of pulmonary embolism (PE)). In cancer patients, the risk of developing VTE is high and constitutes a negative prognostic factor for cancer; the risk of bleeding is also increased. The study of VTE in the context of cancer is a major challenge, given the frequency of the association, the heterogeneity of the situations, the risk factors involved and the therapeutic issues in both curative and primary prevention; in this field, many uncertainties remain, justifying a study focused on the association of VTE and cancer.
Detailed description
Cancer is associated with a higher risk of VTE and mortality. This association is characterized by various uncertainties at pathophysiological, diagnostic, therapeutic and prognostic levels. CAPE STUDY is a prospective, single-center interventional cohort follow-up study designed to investigate the risk of recurrence of VTE and its mechanisms in cancer patients. The study involves the collection of biological samples from cancer patients with venous thromboembolic disease. At inclusion and in case of recurrence of thrombosis or hemorrhage: * Blood samples will be taken for analysis and to constitute a biobank for future assays. * Urine samples will be collected Once a year for 5 years (and adapted to the clinical context): visit as part of routine care, or mailing of a questionnaire, or telephone contact.
Interventions
Collecte of blood and urine samples
Sponsors
University Hospital, Brest
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and more. * Patients with active cancer or requiring cancer treatment at the time of their VTE episode * Patients with documented VTE less than 2 years old * Patients affiliated to the social security system * Patient who has signed a written informed consent
Exclusion criteria
* Patient under 18 * Refusal to participate * Incapacity to consent to the study * Patient under guardianship * Incapacity to communicate (comprehension disorder) * Life expectancy of less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous thromboembolic recurrence | 5 years | Venous thromboembolic recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major hemorrhage | As long as the patient is on anticoagulant treatment during the 5 years of follow-up | Fatal haemorrhage, clinical haemorrhage associated with a fall in haemoglobin of 2g/dl or more, clear clinical haemorrhage requiring transfusion of at least 2 red blood cells packed, intracranial, medullary, retroperitoneal, pericardial, intra-articular, intra-muscular, intra-ocular, intra-pulmonary haemorrhage, any other haemorrhage considered serious by the investigator |
| Mortality | 5 years | Global (all causes) and secondary to recurrent VTE or hemorrhage |
| Arterial events | 5 years | Atrial fibrillation, cerebrovascular accident, coronary accident, arteriopathy of the lower limbs, digestive vascular accident (splanchnic, renal, mesenteric etc.). |
Contacts
Primary ContactFrançis Couturaud, Pr
Outcome results
None listed