RecruitingNCT06694779

Thrombosis in Diffuse Large B-cell Lymphoma:the PREDIC-TO (PREDICt ThrOmbosis) Study

Thrombosis in Diffuse Large B-cell Lymphoma: Impact on Outcome, Evaluation, and Comparison of Predictive Models of Thrombotic Risk: Multicentre Retrospective Observational Study. the PREDIC-TO (PREDICt ThrOmbosis) Study


Sponsor

Fondazione IRCCS San Gerardo dei Tintori

Enrollment

1,000 participants

Start Date

May 25, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Subjects aged ≥ 18 years
  • Histological diagnosis of DLBCL
  • Informed consent freely given and obtained

Exclusion Criteria3

  • 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

Locations(1)

Ivan Civettini

Monza, Italy, Italy

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NCT06694779


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