The Gynecological Cancer Associated Thrombosis (GynCAT) Study

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06284343
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anticoagulant — DRUG
    Prescription of pharmacological thromboprophylaxis according to current clinical practice and international guidelines recommendation

Study Details

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.

Key Dates

First listed
Feb 28, 2024
Start date
Apr 15, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
1,800 participants (estimated)

Arms

  • Arm: Patients affected by Gynecologic Cancer undergoing systemic antineoplastic treatment
    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

Primary Outcome Measure

Number of Participants with Venous thromboembolism [ Time Frame: Follow-up will continue until one of the following censoring events will occur: • EpPatients will be evaluated with one in-person medical visit at enrollment, followed by one telephone visit and one in-person examination at 6 and 12 months, respectively. ]

Central Contacts

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