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Completed
NCT06694779
Thrombosis in Diffuse Large B-cell Lymphoma:the PREDIC-TO (PREDICt ThrOmbosis) Study
Conditions: Diffuse Large B Cell Lymphoma, Thrombosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1504
Sponsor: Fondazione IRCCS San Gerardo dei Tintori
Location: Ivan Civettini Monza
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Subjects aged ≥ 18 years
* Histological diagnosis of DLBCL
* Informed consent freely given and obtained
Exclusion Criteria:
* Active anticoagulant therapy at the time of diagnosis
* Start of prophylactic heparin following diagnosis
* Absence of necessary data to extrapolate risk scores (Khorana, Throly and Model IX) at diagnosis
Source: ClinicalTrials.gov (NCT06694779). StuddyBuddy aggregates publicly available trial information.