Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805, France
Location status: Recruiting
NCT Number: NCT06051214
Coagulation is a complex system which, through the action of thrombin, leads to the formation of fibrin, which stabilises the platelet clot. Any disturbance in the balance between procoagulant and anticoagulant factors can tip the physiological process either towards a state of hypercoagulability leading to thrombosis or hypocoagulability responsible for bleeding.
Due to a number of factors, cancer is associated with a state of hypercoagulability, leading to thrombosis. The incidence of venous thromboembolism (VTE) in cancer patients varies from 15 to 20% depending on the type of cancer, the stage of the disease and the associated treatments (ONCORIF data, November 2021). The risk of venous thromboembolism (VTE) is greatly increased in cancer patients (RR x 3 to 6) and doubled in the case of associated chemotherapy (1). VTE is a poor prognostic factor, occurs mainly in the first 6 months after diagnosis and is the second leading cause of death in cancer patients.
At present, haemostasis tests performed in medical laboratories independently explore the different coagulation pathways but do not allow the overall haemostatic profile of a hyper- or hypocoagulable patient to be assess.
Based on this knowledge base, the aim of our study will be to monitor thrombogram profiles during the management of patients with tumours at high risk of thromboembolism (lung, pancreas, stomach, glioblastoma) and to correlate these profiles with the risk of a thromboembolic event occurring in these patients. The aim of the project is to validate a simple predictive test (suitable for clinical use) for the risk of thromboembolism in these patients. These analyses will also make it possible to monitor the impact of chemotherapy on changes in the thrombin generation test in patients.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Saint-Herblain, 44805, France
Location status: Recruiting
Biological blood samples will be taken specifically for research purposes. As far as possible and depending on the patient's schedule, a sample will be taken every month (during a consultation and/or a course of chemotherapy) and for the 12 months following the initiation of systemic treatment
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
blood sampling every month for 12 months
Time frame: 12 months
Venous thromboembolism (VTE)-free survival.
Time frame: Every 3 months for 12 months
Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min)
Time frame: Every 3 months for 12 months
Analysis of Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min) will be done before and after metastatic progression, or at each progression for patients with immediate metastatic disease.
Time frame: Every 3 months for 12 months
Homogeneous patient trajectories will be identified by evolution of Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min)
Contact information is provided by the study sponsor or research team.
Institut Cancerologie de l'Ouest
Other
Acronym: THROMBIN
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