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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06393764
Other study ID # 29BRC21.0290
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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