Health TrialsbyHealthPanel

Cancer-related Venous Thromboembolic Disease - Cohort Study

ConditionsThrombosis EmbolismThromboses, VenousCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient under 18

Refusal to participate

Incapacity to consent to the study

Patient under guardianship

Trial population

Major cancer patients with venous thromboembolic disease

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Collection of biological samples

    Other intervention

    Collecte of blood and urine samples

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Cancer patients treated for MVTE1 intervention

Trial outcomes

Primary outcomes

1

Venous thromboembolic recurrence

Venous thromboembolic recurrence

Time frame
5 years

Secondary outcomes

1

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

Time frame
As long as the patient is on anticoagulant treatment during the 5 years of follow-up
2

Mortality

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

Time frame
5 years
3

Arterial events

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Brest

Lead sponsor

Source ClinicalTrials.gov
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