Trial Title:
Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis
NCT ID:
NCT06386107
Condition:
Cancer
Pulmonary Embolism
Thrombosis
Conditions: Official terms:
Pulmonary Embolism
Thrombosis
Embolism
Hemorrhage
Thrombin
Conditions: Keywords:
Cancer
Thrombosis
Anticoagulant associated bleeding
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Thrombin Generation Assay (TGA)
Description:
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.
Arm group label:
Patients with cancer associated thrombosis under curative anticoagulant treatment
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.
Detailed description:
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.
Criteria for 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 (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 blinded therapy will be
excluded.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Zip:
63003
Country:
France
Contact:
Last name:
Jeannot SCHMIDT, MD PHD
Investigator:
Last name:
Jeannot SCHMIDT, MD PHD
Email:
Principal Investigator
Investigator:
Last name:
Aurélien LEBRETON, MD PHD
Email:
Sub-Investigator
Investigator:
Last name:
Fares MOUSTAFA, MD PHD
Email:
Sub-Investigator
Investigator:
Last name:
Nicolas DUBLANCHET, MD
Email:
Sub-Investigator
Investigator:
Last name:
Dorian TEISSANDIER, MD
Email:
Sub-Investigator
Facility:
Name:
CHU de Grenoble
Address:
City:
Grenoble
Zip:
38043
Country:
France
Contact:
Last name:
Gilles PERNOD, MD PHD
Phone:
04 76 76 57 17
Phone ext:
+33
Email:
gpernod@chu-grenoble.fr
Investigator:
Last name:
Gilles PERNOD, MD PHD
Email:
Principal Investigator
Investigator:
Last name:
Raphaël MARLU, MD PHD
Email:
Sub-Investigator
Facility:
Name:
HCL
Address:
City:
Lyon
Country:
France
Contact:
Last name:
Yesim DARGAUD, MD PHD
Investigator:
Last name:
Judith CATELLA, MD
Email:
Principal Investigator
Investigator:
Last name:
Claire GRANGE, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yesim DARGAUD, MD PHD
Email:
Sub-Investigator
Facility:
Name:
Chu St-Etienne
Address:
City:
Saint-Étienne
Zip:
42055
Country:
France
Contact:
Last name:
Géraldine POENOU, MD PHD
Email:
geraldine.poenou@chu-st-etienne.fr
Investigator:
Last name:
Laurent BERTOLETTI, MD PHD
Email:
Sub-Investigator
Investigator:
Last name:
Xavier DELAVENNE, MD PHD
Email:
Sub-Investigator
Investigator:
Last name:
Coline LEGENDRE, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pauline NOYEL, MD
Email:
Sub-Investigator
Investigator:
Last name:
Brigitte TARDY, MD PHD
Email:
Sub-Investigator
Investigator:
Last name:
Géraldine POENOU, MD PHD
Email:
Principal Investigator
Start date:
February 2025
Completion date:
February 2027
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Saint Etienne
Agency class:
Other
Collaborator:
Agency:
Diagnostica Stago
Agency class:
Industry
Collaborator:
Agency:
LEO Pharma
Agency class:
Industry
Collaborator:
Agency:
Ligue contre le cancer, France
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Saint Etienne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06386107
