Cancer-related Venous Thromboembolic Disease - Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of biological samples.
- Who it may be relevant to
- Registry conditions: Thrombosis Embolism, Thromboses, Venous, Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Establishment of a Patient-based Cohort : Cancer-related Venous Thromboembolic Disease.
Overview
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
- Other Collection of biological samples
Collecte of blood and urine samples
Primary outcome measures
- Venous thromboembolic recurrence [Time frame: 5 years]
Secondary outcome measures (3)
- Major hemorrhage [Time frame: As long as the patient is on anticoagulant treatment during the 5 years of follow-up]
- Mortality [Time frame: 5 years]
- Arterial events [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Brest University Hospital — Brest
Identifiers
NCT: NCT06393764 · 29BRC21.0290