Assessing blood clot risk in women with gynecological cancers
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
This study is testing a new way to predict blood clot risks in women starting treatment for gynecological cancers to help doctors make better decisions about preventing clots.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06284343 on ClinicalTrials.gov |
What this trial studies
The GynCAT study is a prospective cohort investigation focusing on female patients with gynecologic malignancies who are about to start systemic antineoplastic treatment. It aims to develop and validate a Risk Assessment Model (RAM) specifically for predicting the risk of venous thromboembolism (VTE) in this population. The study will exclude patients with symptomatic VTE at screening and will assess the Khorana Risk Score (KRS) to guide thromboprophylaxis decisions. Data on clinical, hematological, biochemical, coagulation, and genetic factors will be collected throughout the treatment period to monitor VTE events, bleeding, and mortality.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with a diagnosis of gynecologic neoplasm who are scheduled to begin a new line of systemic antineoplastic treatment.
Not a fit: Patients who are pregnant, breastfeeding, or already receiving therapeutic anticoagulant therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of VTE in women undergoing treatment for gynecological cancers.
How similar studies have performed: While existing risk prediction models like the Khorana Risk Score have been used, this study aims to create a novel model specifically validated for gynecological cancer patients, addressing limitations seen in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Rome
- Agostino Gemelli University Polyclinic Foundation IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Roberto Pola, PhD; MD — Agostino Gemelli University Polyclinic Foundation IRCCS
- Study coordinator: Roberto Pola, PhD; MD
- Email: roberto.pola@policlinicogemelli.it
- Phone: +39 0630157075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.