Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06393764

Cancer-related Venous Thromboembolic Disease - Cohort Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Thrombosis Embolism Cancer Cardiovascular Diseases Embolism and Thrombosis Neoplasms Thromboses, Venous Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brest University Hospital

Brest, 29200, France

Location status: Recruiting

Location contact

Francis Couturaud, Prof

CONTACT

[email protected]

+33298347348

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of biological samples

Other

Collecte of blood and urine samples

Primary outcomes

  1. Venous thromboembolic recurrence

    Time frame: 5 years

    Venous thromboembolic recurrence

Secondary outcomes

  1. Major hemorrhage

    Time frame: 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

  2. Mortality

    Time frame: 5 years

    Global (all causes) and secondary to recurrent VTE or hemorrhage

  3. Arterial events

    Time frame: 5 years

    Atrial fibrillation, cerebrovascular accident, coronary accident, arteriopathy of the lower limbs, digestive vascular accident (splanchnic, renal, mesenteric etc.).

Study contacts

Contact information is provided by the study sponsor or research team.

Françis Couturaud, Pr

CONTACT

[email protected]

+33298347348

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: CAPE

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
May 1, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.