Cancer-related Venous Thromboembolic Disease - Cohort Study

NCT ID: NCT06393764

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2034-11-30

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.

Conditions

Thrombosis Embolism; Thromboses, Venous; Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer patients treated for MVTE

All the patients are included in one arm. They will undergo various type of samples.

Collection of biological samples

Intervention Type: OTHER

Collecte of blood and urine samples

Interventions

Collection of biological samples

Collecte of blood and urine samples

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Françis Couturaud, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Brest

Central Contacts

Françis Couturaud, Pr

Role: CONTACT

francis.couturaud@chu-brest.fr

+33298347348

Other Identifiers

29BRC21.0290

Identifier Type: -

Identifier Source: org_study_id