Prospective Observational Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 242
- 试验地点
- 34
- 主要终点
- Number of patients with abnormal Body Mass Index (BMI)
研究概览
简要总结
This is a prospective observational study that will enroll patients with high-risk Polycythemia Vera (PV) with at least one Thromboembolic Event (TE) after diagnosis or up to 2 years prior to diagnosis.
This is a non-randomized study, and to ensure a sufficient number of patients in both cohorts, enrollment in each cohort will be terminated once the target of 150 patients has been reached.
详细描述
All patients are already on treatment with hydroxyurea or ruxolitinib at enrollment as per clinical practice and independently of their participation in this study. In addition, the follow-up visits and the evaluation procedures required in the study protocol correspond to current clinical practice. According to local regulations related to observational studies, assessments such as blood tests are justified by the purpose and rationale of the study (i.e., the identification of possible predictive factors of TEs) and are considered current clinical practice. Data related to other procedures will be collected only if such procedures are performed as per clinical practice but are not required otherwise.
Patients in both cohorts will be followed for 3 years after enrollment and will have visits at Months 6, 12, 18, 24, 30 and 36. A time window of ± 1 month is permitted for all visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Age ≥18 years.
- •Diagnosis of PV according to WHO 2008 or WHO 2016 and high-risk stratification according to European LeukemiaNet (ELN) classification.
- •At least one TE after diagnosis or up to 2 years prior to diagnosis.
- •Patients on treatment with hydroxyurea at enrollment and for at least 18 months prior to enrollment or those on treatment with ruxolitinib who started treatment up to 18 months before enrollment.
排除标准
- 未提供
结局指标
主要结局
Number of patients with abnormal Body Mass Index (BMI)
时间窗: Up to month 36
Number of patients with abnormal Body Mass Index (BMI) will be collected
Blood pressure
时间窗: Up to month 36
Blood pressure is going to be collected
Number of patients with abnormal weight
时间窗: Up to month 36
Number of patients with abnormal weight will be collected
Number of patients with abnormal Neutrophil (NEP) count
时间窗: Up to 36 months
Number of patients with abnormal Neutrophil (NEP) count will be collected
Percentage of abnormalities presented in patients with Thromboembolic Events (TEs) during the follow up
时间窗: Up to 36 months
Demographics, blood pressure, laboratory blood tests, and use of antiplatelets and/or anticoagulants are predictors of TE occurrence, a univariate Cox regression model for repeated events will be applied for each predictor considering all the TEs occurring within 12 months and the time from baseline to each occurrence. Predictors found statistically significant at the 5% level will then be considered in a multivariate Cox regression model for repeated events.
Number of participants using antiplatelets and/or anticoagulants on the incidence of TEs
时间窗: Up to 36 months
Number of participants using antiplatelets and/or anticoagulants on the incidence of Thromboembolic Events (TEs) will be collected
Number of patients with abnormal White blood Count (WBC)
时间窗: Up to 36 months
Number of patients with abnormal White blood Count (WBC) will be collected
Number of patients with abnormal Lymphocytes (LYP) count
时间窗: Up to 36 months
Number of patients with abnormal Lymphocytes (LYP) count will be collected
次要结局
- Yearly incidence of TEs(36 months)
- Incidence of arterial and venous TEs in the hydroxyurea and ruxolitinib cohorts(36 months)
- Synergistic combinations of predictive factors(Up to 36 months)
- Incidence and severity of adverse events(36 months)