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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02175-40 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Diagnostica Stago | INDUSTRY |
| LEO Pharma | INDUSTRY |
| Ligue contre le cancer, France | OTHER |
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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.
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. Existing models for predicting anticoagulant associated bleeding risk applied to the CAT patients are not very predictive (AUC<0.60). 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 wish 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with cancer associated thrombosis under curative anticoagulant treatment | Experimental | Patients with cancer associated thrombosis under curative anticoagulant treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombin Generation Assay (TGA) | Biological | Hemostasis is a complex process in which genetic or environmental conditions can cause shifts either towards pro-thrombotic states resulting in thrombosis, or towards pro-hemorrhagic states resulting in uncontrolled bleeding. Tests to assess a more global hemostatic profile, such as the TGA, have appeared as a more reliable alternative to assess the real hemostatic capacity of an individual. TGA is a global dynamic assay simultaneously and continuously measuring thrombin generation. It monitors the cleavage of a fluorigenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample. |
| Measure | Description | Time Frame |
|---|---|---|
| The measurement of the area under the curve ( endogenious thrombin potential) nMxmin | The measurment of the endogenious thrombin potential, during the first 6 months of treatment | during the first 6 months of treatment |
| the measurement of the lag time unit = seconds | the measurement of the lag time, during the first 6 months of treatment | during the first 6 months of treatment |
| the measurement of the peak height unit = nm | the measurement of the peak height during the first 6 months of treatment. | during the first 6 months of treatment |
| the measurement of the time to peak unit = seconds | the mesearurement of the time to peak, during the first 6 months of treatment. | during the first 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of adding TGT results on the performance of bleeding risk prediction scores | Effect of adding TGT results on the performance (via AUC) of bleeding risk prediction scores. | Month 1; Month 6 |
| Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Géraldine POENOU, MD PHD | Contact | (0)477828919 | +33 | geraldine.poenou@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Géraldine POENOU, MD PHD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont-Ferrand | Not yet recruiting | Clermont-Ferrand | 63003 | France |
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Prospective cohort of consecutive patients initiating full-dose anticoagulant therapy for an episode of CAT, followed up until the 6th month of treatment to assess the risk of clinically relevant adjunctive bleeding events and any other adverse event during anticoagulant therapy (recurrence of CAT, death).
TGT measurement is fully automated and calibrated with quality control.
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Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT (between inclusion and m1) |
| Month 1; Month 6 |
| Occurrence of an event of interest under treatment | Occurrence of an event of interest under treatment (recurrence of CAT, death, clinically relevant bleeding event) during the 6 months of follow-up, according to the TGT assessment at inclusion. | Month : 1 to 6 |
| CHU de Grenoble | Not yet recruiting | Grenoble | 38043 | France |
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| HCL | Not yet recruiting | Lyon | France |
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| Chu St-Etienne | Recruiting | Saint-Etienne | 42055 | France |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D011655 | Pulmonary Embolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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