Actively Recruiting
Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk
Led by Institut Cancerologie de l'Ouest · Updated on 2026-02-17
200
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
I
Institut Cancerologie de l'Ouest
Lead Sponsor
D
Diagnostica Stago
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged > 18 years
- Diagnosis of solid cancer with high risk of thrombosis (lung, pancreatic, gastric, or glioblastoma cancer)
- No prior systemic treatment for cancer
- Provided informed consent for data use and biological sample collection
You will not qualify if you...
- History of venous thromboembolism in the 12 months before cancer diagnosis
- Current use of low molecular weight heparins, standard unfractionated heparins, or anti-vitamin K medications
- Pregnant, breastfeeding, or likely to become pregnant
- Under legal protection such as custody, guardianship, or court supervision
- Unable to comply with medical monitoring due to geographic, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institut de Cancerologie de L'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
Research Team
A
Armelle LEFRANCOIS
CONTACT
L
LAETITIA HIMPE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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