Clinical and Laboratory Characteristics of Polycythemia Vera
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,150
- 试验地点
- 22
- 主要终点
- Long-term survival
研究概览
简要总结
The study is observational, longitudinal, retrospective and prospective, on patients with PV. Patients with PV diagnosed from 2000 to 2023 according to WHO2017 criteria will be considered. The main purpose of the study is to determine the impact of clinical and laboratory characteristics of Polycythemia Vera on patients' prognosis, understood as long-term survival
详细描述
The structured collection of data necessary for the evaluation of the objectives will take place through the creation of a specific electronic archive with an expected duration of 7 years, possibly extendable. The electronic archive may be used to review case histories and to obtain or confirm new scientific evidence on Polycythemia Vera. Patients will be followed and treated within the care pathway provided by normal clinical practice.
The following elements will be considered in each patient: age, recent and remote pathological history, characteristics of PV onset, histological, cytogenetic and molecular investigations of diagnostic definition, medical therapies performed, type of response to the therapies performed, complications of these therapies and pathology. All useful data will be collected exclusively through consultation of outpatient medical records.
The planned enrollment period is 60 months (January 2019-December 2023). The observation period of enrolled patients is at least 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients diagnosed with PV according to WHO 2017 criteria,
- •Obtaining informed consent for data collection and processing
排除标准
- 未提供
结局指标
主要结局
Long-term survival
时间窗: 6 years
To determine the impact of clinical and laboratory characteristics of Polycythemia Vera (PV) on patients' prognosis, in terms of lon term survival
次要结局
- Therapies Efficacy(6 years)
- Evolution to acute leukemias(6 years)
- Thrombosis(6 years)
- Haemorrhages(6 years)
- Therapies(6 years)
- Therapies Toxicity(6 years)
- Development of second neoplasms(6 years)