Establishment of a Patient-based Cohort : Cancer-related Venous Thromboembolic Disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University Hospital, Brest
- Enrollment
- 150
- Primary Endpoint
- Venous thromboembolic recurrence
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Venous thromboembolic recurrence
Time Frame: 5 years
Venous thromboembolic recurrence
Secondary Outcomes
- Arterial events(5 years)
- Mortality(5 years)
- Major hemorrhage(As long as the patient is on anticoagulant treatment during the 5 years of follow-up)