Clinical trial NCT06393764: Cancer-related Venous Thromboembolic Disease - Cohort Study
Official title: Establishment of a Patient-based Cohort : Cancer-related Venous Thromboembolic Disease.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thrombosis Embolism
Thromboses, Venous
Cancer
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major cancer patients with venous thromboembolic disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Venous thromboembolic recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Major hemorrhage
timeFrame: As long as the patient is on anticoagulant treatment during the 5 years of follow-up
measure: Mortality
timeFrame: 5 years
measure: Arterial events
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: CHU Brest
name: Françis Couturaud, Pr
role: PRINCIPAL_INVESTIGATOR
References: