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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient aged \> 18 years,

• Patient with a solid cancer at high risk of thrombosis, whether metastatic or not (lung, pancreatic, gastric or glioblastoma cancers)1,

• Patients who have not received any systemic treatment for their cancer,

• An informed patient who does not object to the use of data for research purposes and who has consented to the collection, use and storage of biological samples.

Locations
Other Locations
France
Institut de Cancerologie de L'Ouest
RECRUITING
Saint-herblain
Contact Information
Primary
Armelle LEFRANCOIS
armelle.lefrançois@ico.unicancer.fr
+33240679727
Backup
LAETITIA HIMPE
laetitia.himpe@ico.unicancer.fr
+33240679747
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2026-09
Participants
Target number of participants: 200
Treatments
Experimental: Thrombogram
Blood sampling every month for 12 months
Sponsors
Leads: Institut Cancerologie de l'Ouest
Collaborators: Diagnostica Stago

This content was sourced from clinicaltrials.gov