NCT06051214 Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk
| NCT ID | NCT06051214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Cancerologie de l'Ouest |
| Condition | Solid Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-09-12 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patient aged \> 18 years, 2. Patient with a solid cancer at high risk of thrombosis, whether metastatic or not (lung, pancreatic, gastric or glioblastoma cancers)1, 3. Patients who have not received any systemic treatment for their cancer, 4. 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. Exclusion Criteria: 1. Patient who has had a VTE in the 12 months preceding the diagnosis of cancer, 2. Patient on low molecular weight heparins, standard unfractionated heparins and anti-vitamin K2, 3. Women who are pregnant, likely to become pregnant or who are breast-feeding, 4. Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian, 5. Unable to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Contact & Investigator
Judith RAIMBOURG, MD
PRINCIPAL INVESTIGATOR
INSTITUT DE CANCEROLOGIE DE L'OUEST
Frequently Asked Questions
Who can join the NCT06051214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06051214 currently recruiting?
Yes, NCT06051214 is actively recruiting participants. Contact the research team at armelle.lefrançois@ico.unicancer.fr for enrollment information.
Where is the NCT06051214 trial being conducted?
This trial is being conducted at Saint-Herblain, France.
Who is sponsoring the NCT06051214 clinical trial?
NCT06051214 is sponsored by Institut Cancerologie de l'Ouest. The principal investigator is Judith RAIMBOURG, MD at INSTITUT DE CANCEROLOGIE DE L'OUEST. The trial plans to enroll 200 participants.