The Gynecological Cancer Associated Thrombosis (GynCAT) Study (GynCAT)

September 17, 2024 updated by: Pola Roberto, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Anticoagulant
Prescription of pharmacological thromboprophylaxis according to current clinical practice and international guidelines recommendation
Other Names:
  • Apixaban
  • Rivaroxaban
  • Low Molecular Weight Heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Bleeding events (major and clinically relevant non-major bleeding)
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.
After acquisition and review of the clinical documentation related to a hemorrhagic event, bleeding will be assigned if requirements for major or clinically relevant nonmajor bleeding are met, as defined by the International Society on Thrombosis and Haemostasis (ISTH)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Fondazione Umberto Veronesi

Investigators

  • Principal Investigator: Roberto Pola, PhD; MD, Agostino Gemelli University Polyclinic Foundation IRCCS
  • Study Chair: Paolo Santini, MD, Agostino Gemelli University Polyclinic Foundation IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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