protocolSection identificationModule nctId: NCT06386107, orgStudyIdInfo id: 23PH188, secondaryIdInfos id: 2023-A02175-40, type: OTHER, domain: ANSM, briefTitle: Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis, acronym: CATforCAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, collaborators name: Diagnostica Stago, collaborators name: LEO Pharma, collaborators name: Ligue contre le cancer, France, descriptionModule briefSummary: 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., conditionsModule conditions: Cancer, conditions: Pulmonary Embolism, conditions: Thrombosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 212, type: ESTIMATED, armsInterventionsModule interventions name: Thrombin Generation Assay (TGA), outcomesModule primaryOutcomes measure: The measurement of the area under the curve ( endogenious thrombin potential) nMxmin, primaryOutcomes measure: the measurement of the lag time unit = seconds, primaryOutcomes measure: the measurement of the peak height unit = nm, primaryOutcomes measure: the measurement of the time to peak unit = seconds, secondaryOutcomes measure: Effect of adding TGT results on the performance of bleeding risk prediction scores, secondaryOutcomes measure: Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT, secondaryOutcomes measure: Occurrence of an event of interest under treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Clermont-Ferrand, city: Clermont-Ferrand, zip: 63003, country: France, contacts name: Jeannot SCHMIDT, MD PHD, role: CONTACT, contacts name: Jeannot SCHMIDT, MD PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Aurélien LEBRETON, MD PHD, role: SUB_INVESTIGATOR, contacts name: Fares MOUSTAFA, MD PHD, role: SUB_INVESTIGATOR, contacts name: Nicolas DUBLANCHET, MD, role: SUB_INVESTIGATOR, contacts name: Dorian TEISSANDIER, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU de Grenoble, city: Grenoble, zip: 38043, country: France, contacts name: Gilles PERNOD, MD PHD, role: CONTACT, phone: 04 76 76 57 17, phoneExt: +33, email: gpernod@chu-grenoble.fr, contacts name: Gilles PERNOD, MD PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Raphaël MARLU, MD PHD, role: SUB_INVESTIGATOR, geoPoint lat: 45.16667, lon: 5.71667, locations facility: HCL, city: Lyon, country: France, contacts name: Yesim DARGAUD, MD PHD, role: CONTACT, contacts name: Judith CATELLA, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Claire GRANGE, MD, role: SUB_INVESTIGATOR, contacts name: Yesim DARGAUD, MD PHD, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Chu St-Etienne, city: Saint-Étienne, zip: 42055, country: France, contacts name: Géraldine POENOU, MD PHD, role: CONTACT, email: geraldine.poenou@chu-st-etienne.fr, contacts name: Laurent BERTOLETTI, MD PHD, role: SUB_INVESTIGATOR, contacts name: Xavier DELAVENNE, MD PHD, role: SUB_INVESTIGATOR, contacts name: Coline LEGENDRE, MD, role: SUB_INVESTIGATOR, contacts name: Pauline NOYEL, MD, role: SUB_INVESTIGATOR, contacts name: Brigitte TARDY, MD PHD, role: SUB_INVESTIGATOR, contacts name: Géraldine POENOU, MD PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False