The Gynecological Cancer Associated Thrombosis (GynCAT) Study

Trial Title: The Gynecological Cancer Associated Thrombosis (GynCAT) Study

NCT ID: NCT06284343

Condition: Cancer-associated Thrombosis
Venous Thromboembolism
Gynecologic Cancer
Ovarian Cancer
Cervix Cancer
Endometrial Cancer
Vaginal Cancer

Conditions: Official terms:
Ovarian Neoplasms
Endometrial Neoplasms
Vaginal Neoplasms
Uterine Cervical Neoplasms
Thrombosis
Thromboembolism
Venous Thromboembolism
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Rivaroxaban
Apixaban
Anticoagulants

Conditions: Keywords:
Thrombosis
Venous thromboembolism
Cancer
Ovarian Cancer
Vaginal Cancer
Endometrial Cancer
Gynecologic Cancer

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Anticoagulant
Description: Prescription of pharmacological thromboprophylaxis according to current clinical practice and international guidelines recommendation
Arm group label: Patients affected by Gynecologic Cancer undergoing systemic antineoplastic treatment

Other name: Low Molecular Weight Heparin

Other name: Apixaban

Other name: Rivaroxaban

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.

Detailed description: Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk. GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded. The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRS≥3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population. The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine & Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes. In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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.

Gender: Female

Gender based: Yes

Gender description: Patients affected by Gynecologic Cancer

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Agostino Gemelli University Polyclinic Foundation IRCCS

Address:
City: Rome
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Roberto Pola, PhD; MD

Phone: +39 0630157075
Email: roberto.pola@policlinicogemelli.it

Contact backup:
Last name: Paolo Santini, MD
Email: paolo.santini@guest.policlinicogemelli.it

Investigator:
Last name: Paolo Santini, MD
Email: Sub-Investigator

Start date: April 15, 2024

Completion date: September 30, 2026

Lead sponsor:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Collaborator:
Agency: Fondazione Umberto Veronesi
Agency class: Other

Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06284343