GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment, aiming at development and validation of a Risk Assessment Model (RAM) for Venous Thromboembolism (VTE) in this specific population.
Female sex;
Diagnosis of gynecologic neoplasm (ovarian, tubal, uterine, cervical, vaginal, vulvar neoplasm);
Planned new line of systemic antineoplastic treatment;
Age of 18 years or older;
Pregnant or breastfeeding women;
Indication to receive therapeutic dose anticoagulant therapy (e.g., atrial fibrillation, mechanical heart valve);
Diagnosis of symptomatic VTE at the time of screening for enrollment.
Study population will consist of subsequent patients prospectively enrolled at the time of prescription of a new line of systemic antineoplastic treatment for a gynecologic oncological disease, defined as ovarian, tubal, uterine, cervical, vaginal, or vulvar neoplasm. Patients will be recruited in the setting of the Gynecologic Oncology Day Hospital and evaluated by the Thrombosis Clinic of the Agostino Gemelli University Polyclinic Foundation I.R.C.C.S. in Rome.
Cohort
Prospective
Anticoagulant
DrugPrescription of pharmacological thromboprophylaxis according to current clinical practice and international guidelines recommendation
Number of Participants with Venous thromboembolism
Venous Thromboembolism (VTE) diagnosis will be assigned in case of objective confirmation by venous duplex ultrasonography and/or contrast enhanced CT and/or MRI and/or ventilation/perfusion SPECT. In case of death during follow-up, clinical documentation and/or autopsy findings, if available, will be reviewed to assess for the presence of a possible diagnosis of fatal pulmonary embolism. VTE events will be independently judged by an external committee, constituted by Angiology and Radiology experts, blinded to patients' clinical history and laboratory parameters. Incidentally detected VTE events will be considered as events, provided their eligibility by the aforementioned external committee.
Number of Participants with Bleeding events (major and clinically relevant non-major bleeding)
After acquisition and review of the clinical documentation related to a hemorrhagic event, bleeding will be assigned if requirements for major or clinically relevant nonmajor bleeding are met, as defined by the International Society on Thrombosis and Haemostasis (ISTH)
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Fondazione Umberto Veronesi
Collaborator
