CancerCATforCATNCT06386107
Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis
A study testing Thrombin Generation Assay (TGA) in people with Cancer and Pulmonary Embolism, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Pulmonary Embolism, Thrombosis
- What is being tested?
- Thrombin Generation Assay (TGA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Sep 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Clémence MENU, MD
Jeannot SCHMIDT, MD PHD
- Not yet recruiting
CHU de Grenoble
Grenoble, 38043
Felix GARCIN, MD, 06 82 15 76 69 ext. +33, fgarcin@chu-grenoble.fr
Felix GARCIN, MD
- Not yet recruiting
HCL
Lyon
Yesim DARGAUD, MD PHD
Judith CATELLA, MD
- Recruiting
Chu St-Etienne
Saint-Etienne, 42055
Géraldine POENOU, MD PHD, geraldine.poenou@chu-st-etienne.fr
Laurent BERTOLETTI, MD PHD
About this study
Official title: Association Between Thrombin Generation Parameters and the Risk of Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis (CAT) (a Multicenter Study)
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.
Read the 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.
- Conditions
- Cancer, Pulmonary Embolism, Thrombosis
- Being tested
- Thrombin Generation Assay (TGA)
- Keywords
- Cancer, Thrombosis, Anticoagulant associated bleeding
- Medical subject headings
- Neoplasms, Pulmonary Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer associated thrombosis under curative anticoagulant treatment | Experimental | Patients with cancer associated thrombosis under curative anticoagulant treatment. Receives: Biological: Thrombin Generation Assay (TGA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: during the first 6 months of treatment
Secondary outcomes (3)
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.
Measured: Month 1; Month 6
Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT
Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT (between inclusion and m1)
Measured: 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.
Measured: Month : 1 to 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start2 Sep 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Diagnostica Stago, LEO Pharma, Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Géraldine POENOU, MD PHD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386107
- Sponsor's protocol ID
- 23PH188
- Other IDs
- 2023-A02175-40
- Acronym
- CATforCAT
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Thrombin Generation Parameters and the Risk of Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis (CAT) (a Multicenter Study)
- ClinicalTrials.gov ID
- NCT06386107
- Acronym / sponsor ID
- CATforCAT / 23PH188
- Conditions
- Cancer, Pulmonary Embolism, Thrombosis
- Keywords
- Cancer, Thrombosis, Anticoagulant associated bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Diagnostica Stago, LEO Pharma, Ligue contre le cancer, France
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer associated thrombosis under curative anticoagulant treatment | Experimental | Biological: Thrombin Generation Assay (TGA)Patients with cancer associated thrombosis under curative anticoagulant treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombin Generation Assay (TGA)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. | Biological | Patients with cancer associated thrombosis under curative anticoagulant treatment |
Primary outcome
The measurement of the area under the curve ( endogenious thrombin potential) nMxmin
Time frame: during the first 6 months of treatment
The measurment of the endogenious thrombin potential, during the first 6 months of treatment
the measurement of the lag time unit = seconds
Time frame: during the first 6 months of treatment
the measurement of the lag time, during the first 6 months of treatment
the measurement of the peak height unit = nm
Time frame: during the first 6 months of treatment
the measurement of the peak height during the first 6 months of treatment.
the measurement of the time to peak unit = seconds
Time frame: during the first 6 months of treatment
the mesearurement of the time to peak, during the first 6 months of treatment.
3 secondary outcomes
Effect of adding TGT results on the performance of bleeding risk prediction scores
Time frame: Month 1; Month 6
Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT
Time frame: Month 1; Month 6
Occurrence of an event of interest under treatment
Time frame: Month : 1 to 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Géraldine POENOU, MD PHD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombin Generation Assay (TGA) in people with Cancer and Pulmonary Embolism, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Géraldine POENOU, MD PHD ((0)477828919 ext. +33, geraldine.poenou@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of the area under the curve ( endogenious thrombin potential) nMxmin (time frame: during the first 6 months of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.