Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-associated Thrombosis | — | UNRESOLVED | — |
| Cervix Cancer | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anticoagulant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients affected by Gynecologic Cancer undergoing systemic antineoplastic treatment
- description
- 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
- interventionNames
- Drug: Anticoagulant
Primary outcomes (1)
- measure
- Number of Participants with Venous thromboembolism
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available