Cancer-related Venous Thromboembolic Disease - Cohort Study

Cancer Clinical Trial

— CAPE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393764
• Other study ID #: 29BRC21.0290
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2034

Study information

• Verified date: April 2024
• Source: University Hospital, Brest
• Contact: Françis Couturaud, Pr
• Phone: +33298347348
• Email: francis.couturaud[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2034
• Est. primary completion date: June 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Embolism
• Embolism and Thrombosis
• Thromboembolism
• Thromboses, Venous
• Thrombosis
• Thrombosis Embolism
• Venous Thrombosis

Intervention

Other:
• Collection of biological samples
Collecte of blood and urine samples

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolic recurrence	Venous thromboembolic recurrence	5 years
Secondary	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
Secondary	Mortality	Global (all causes) and secondary to recurrent VTE or hemorrhage	5 years
Secondary	Arterial events	Atrial fibrillation, cerebrovascular accident, coronary accident, arteriopathy of the lower limbs, digestive vascular accident (splanchnic, renal, mesenteric etc.).	5 years