Cancer-related Venous Thromboembolic Disease - Cohort Study (CAPE)

Establishment of a Patient-based Cohort : Cancer-related Venous Thromboembolic Disease.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Thromboses, Venous; Thrombosis Embolism
• Intervention / Treatment: Other: Collection of biological samples

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Françis Couturaud, Pr; Phone Number: +33298347348; Email: francis.couturaud@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Major cancer patients with venous thromboembolic disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer patients treated for MVTE; All the patients are included in one arm. They will undergo various type of samples.	Other: Collection of biological samples; Collecte of blood and urine samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous thromboembolic recurrence	Venous thromboembolic recurrence	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Global (all causes) and secondary to recurrent VTE or hemorrhage	5 years
Arterial events	Atrial fibrillation, cerebrovascular accident, coronary accident, arteriopathy of the lower limbs, digestive vascular accident (splanchnic, renal, mesenteric etc.).	5 years
Major hemorrhage	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	As long as the patient is on anticoagulant treatment during the 5 years of follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Françis Couturaud, Pr, CHU Brest

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2034
• Study Completion (Estimated): November 1, 2034

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Thrombosis; Venous Thrombosis; Embolism; Thromboembolism; Embolism and Thrombosis
• Other Study ID Numbers: 29BRC21.0290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No