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

NCT06694779 | Recruiting

• 1 other identifier: PREDIC-TO
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Measurement of thrombotic events

  Measurement of thrombotic risk factors present in the Khorana, Throly and Model IX scores. Thrombotic events after diagnosis

  From the date of diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) to the occurrence of a thrombotic event (arterial or venous), death, loss to follow-up, or a maximum period of 24 months from diagnosis, whichever comes first.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

-. Patients with a diagnosed of DLBCL from 01/01/2004 until 31/12/2022 can be enrolled in the study

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS San Gerardo dei Tintori: lead
• University of Milano Bicocca: collaborator

Study Sites (1)

Ivan Civettini

Monza, Italy, Italy

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Thrombosis

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

IVan Civettini, M.D.

CONTACT

+39.039.233-9553/-3539; ivancivettini@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: November 19, 2024
• Study Start: May 25, 2023
• Primary Completion: May 25, 2025
• Study Completion (Estimated): May 25, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)