Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284343
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-21
Brief Title:
The Gynecological Cancer Associated Thrombosis GynCAT Study
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GynCAT
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 KRS3 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 1200 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 n1200 and one-third n600 to an independent validation cohort The total number of patients recruited in the study will thus be of 1800 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
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 KRS3 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 1200 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 n1200 and one-third n600 to an independent validation cohort The total number of patients recruited in the study will thus be of 1800 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None