Cancer-related Venous Thromboembolic Disease - Cohort Study

Not yet recruiting

• Conditions: Thromboses, Venous; Cancer; Thrombosis Embolism
• Interventions: Other: Collection of biological samples

• Registration Number: NCT06393764
• Lead Sponsor: University Hospital, Brest

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 Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-05-01
• Status Verified: 2024-11
• Study Start: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2034-11
• Study Completion: 2034-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients treated for MVTE	Collection of biological samples	All the patients are included in one arm. They will undergo various type of samples.

Primary Outcome Measures

Name	Time	Method
Venous thromboembolic recurrence	5 years	Venous thromboembolic recurrence

Secondary Outcome Measures

Name	Time	Method
Arterial events	5 years	Atrial fibrillation, cerebrovascular accident, coronary accident, arteriopathy of the lower limbs, digestive vascular accident (splanchnic, renal, mesenteric etc.).
Mortality	5 years	Global (all causes) and secondary to recurrent VTE or hemorrhage
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