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Comparative Evaluation of Thrombotic Risk Models in DLBCL patients
Objective: To assess the impact of thrombotic risk factors and compare the performance of existing predictive models (Khorana, Throly, Model IX) in Diffuse Large B-cell Lymphoma (DLBCL)
Primary Endpoints:
Measure thrombotic risk factors in existing models Determine occurrence, type, and timing of venous thrombotic events
Secondary Endpoints:
Assess performance of models in patients without thrombotic events at diagnosis Evaluate dynamic risk factors during DLBCL treatment Identify additional risk factors not included in published models Analyze overall survival and VTE-free survival
Methodology:
Real-world cohort study of DLBCL patients Collection of static and dynamic risk factors Correlation analysis of risk factors with thrombotic events Development and validation of DLBCL-specific predictive model
Conclusion:
This study aims to compare existing predictive models and develop a DLBCL-specific model to aid in identifying high-risk patients and inform thromboprophylaxis decisions. Results will contribute to improved understanding and management of thrombotic risk in DLBCL.
Full description
DLBCL is the most frequent lymphoid malignancy in the adult population and the one with the highest risk of thrombotic events. The indications for thromboprophylaxis are, however, debated.
For such reason, risk scores (i.e., the Khorana, Throly and the recently published Model IX score), have been developed to identify patients bearing a high thrombotic risk at diagnosis. These models, however, were developed considering not only aggressive lymphomas, but also indolent lymphomas, characterized by a markedly lower risk of VTE when compared to DLBCL.
The performance of the Khorana, Throly and Model IX score has never been evaluated and compared in the sole DLBCL population. Such understanding in a cohort of "real world" patients could aid clinicians in deciding whether to initiate thromboprophylaxis and may direct randomised controlled trials on the use of prophylactic heparin in the future.
Moreover, the aforementioned scores assess independent variables at diagnosis, not taking into account the possible occurrence of risk factors that may arise over the course of DLBCL treatment or in case of placement of a central venous catheter (CVC).
Assessing the impact of thrombotic risk factors at diagnosis and during the disease, in a cohort of sole DLBCL patients, could allow the development of a new predictive model of thrombotic risk adapted to DLBCL.
Secondary objectives
ENDPOINTS Primary endpoints
Secondary endpoints
Data collection of static thrombotic risk factors at diagnosis and not included in the already published scores:
Correlation between static risk factors at diagnosis and relative risk of thrombotic events
Data collection of dynamic risk factors (as both categorical-dichotomous and temporal variable) present from diagnosis to expected event, death or lost at follow-up:
Correlation between acquisition of dynamic risk factors and relative risk of thrombotic event
Date of thrombotic event, death or lost to follow-up to determine overall survival and VTE free survival
Creation and validation of a predictive model adapted to DLBCL based on the Hazard Ratios of the independent variables
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IVan Civettini, M.D.
Data sourced from clinicaltrials.gov
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