NCT06386107 Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis
| NCT ID | NCT06386107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2025-09-02 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 212 participants in total. It began in 2025-09-02 with a primary completion date of 2027-07.
⚠ 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
Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.
Eligibility Criteria
Inclusion Criteria: * Patients with active cancer, as defined by current French recommendations (Mahé I et al Rev Mal Respir 2021) * Presenting acute proximal deep vein thrombosis of the lower limb (DVT) and/or proximal pulmonary embolism (at least segmental) (PE), confirmed by objective tests (Doppler ultrasound in the event of DVT; lung scintigraphy or CT scan in the event of PE) * No contraindication for anticoagulant treatment at a curative dose at the time of inclusion Exclusion Criteria: * Patients participating in a therapeutic clinical trial with a blinded therapy or an open-label therapeutic trial who are included in the experimental treatment group. * Patients already on anticoagulant at a curative dose for valvular or rhythmic embolic disease or a history of venous thromboembolic disease * Hematological malignancies * Patients with a contraindication to anticoagulant treatment on inclusion * Patient whose relay by DOAC has already been carried out.
Contact & Investigator
Géraldine POENOU, MD PHD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Frequently Asked Questions
Who can join the NCT06386107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386107 currently recruiting?
Yes, NCT06386107 is actively recruiting participants. Contact the research team at geraldine.poenou@chu-st-etienne.fr for enrollment information.
Where is the NCT06386107 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France, Grenoble, France, Lyon, France, Saint-Etienne, France.
Who is sponsoring the NCT06386107 clinical trial?
NCT06386107 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Géraldine POENOU, MD PHD at Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 212 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.