The Gynecological Cancer Associated Thrombosis (GynCAT) Study

NCT ID: NCT06284343

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2026-09-30

Brief 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.

Conditions

Cancer-associated Thrombosis; Venous Thromboembolism; Gynecologic Cancer; Ovarian Cancer; Cervix Cancer; Endometrial Cancer; Vaginal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Anticoagulant

Intervention Type: DRUG

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

Interventions

Anticoagulant

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

Intervention Type: DRUG

Other Intervention Names

Low Molecular Weight Heparin; Apixaban; Rivaroxaban

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Umberto Veronesi

OTHER

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Pola Roberto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Pola, PhD; MD

Role: PRINCIPAL_INVESTIGATOR

Agostino Gemelli University Polyclinic Foundation IRCCS

Paolo Santini, MD

Role: STUDY_CHAIR

Agostino Gemelli University Polyclinic Foundation IRCCS

Locations

Agostino Gemelli University Polyclinic Foundation IRCCS

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberto Pola, PhD; MD

Role: CONTACT

roberto.pola@policlinicogemelli.it

+39 0630157075

Paolo Santini, MD

Role: CONTACT

paolo.santini@guest.policlinicogemelli.it

Facility Contacts

Roberto Pola, PhD; MD

Role: primary

roberto.pola@policlinicogemelli.it

+39 0630157075

Paolo Santini, MD

Role: backup

paolo.santini@guest.policlinicogemelli.it

Other Identifiers

6414

Identifier Type: -

Identifier Source: org_study_id