NCT06051214

Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Solid Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	thrombogram	blood sampling every month for 12 months

Timeline

• Start date: 2023-09-12
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2023-09-22
• Last updated: 2026-02-17

Locations

1 site across 1 country: France