RecruitingNCT06284343

The Gynecological Cancer Associated Thrombosis (GynCAT) Study

Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

1,800 participants

Start Date

Apr 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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;
  • Accordance of Informed Consent.

Exclusion Criteria3

  • 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.

Interventions

DRUGAnticoagulant

Prescription of pharmacological thromboprophylaxis according to current clinical practice and international guidelines recommendation


Locations(1)

Agostino Gemelli University Polyclinic Foundation IRCCS

Rome, Italy

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NCT06284343


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