Evaluating Thrombotic Risk in Diffuse Large B-cell Lymphoma
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
This study is trying to find out which risk factors can help predict blood clots in patients with Diffuse Large B-cell Lymphoma to improve their treatment and care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS San Gerardo dei Tintori Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Monza, Italy) |
| Trial ID | NCT06694779 on ClinicalTrials.gov |
What this trial studies
This study aims to assess thrombotic risk factors in patients with Diffuse Large B-cell Lymphoma (DLBCL) and compare the effectiveness of existing predictive models, such as Khorana, Throly, and Model IX. It will involve a real-world cohort of DLBCL patients, collecting both static and dynamic risk factors to analyze their correlation with thrombotic events. The study seeks to develop a DLBCL-specific predictive model to better guide thromboprophylaxis decisions during treatment. By understanding the thrombotic risk in this specific population, the study hopes to improve patient management and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a histological diagnosis of Diffuse Large B-cell Lymphoma.
Not a fit: Patients currently on active anticoagulant therapy or those who have started prophylactic heparin after diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate thrombotic risk assessments and improved prophylactic strategies for DLBCL patients.
How similar studies have performed: While existing models have been used in broader lymphoma populations, this study is novel in its focused evaluation of thrombotic risk specifically in DLBCL patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Monza, Italy
- Ivan Civettini — Monza, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: IVan Civettini, M.D.
- Email: ivancivettini@gmail.com
- Phone: +39.039.233-9553/-3539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.