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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,504
- 试验地点
- 2
- 主要终点
- Measurement of thrombotic events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥ 18 years
- •Histological diagnosis of DLBCL
- •Informed consent freely given and obtained
排除标准
- •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
结局指标
主要结局
Measurement of thrombotic events
时间窗: 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.
Measurement of thrombotic risk factors present in the Khorana, Throly and Model IX scores. Thrombotic events after diagnosis
次要结局
未报告次要终点