Unmasking Polycythemia Vera in Long-Standing Essential Thrombocythemia: A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 678
- 试验地点
- 24
- 主要终点
- Nested case-control study
研究概览
简要总结
International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).
详细描述
The study will include ET patients (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) who are JAK2V617F positive and have progressed to PV (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) by 31/12/2020. The date of PV diagnosis will be defined as the index date and this group of patients will be defined as ET-to-PV cases.
Part A - Nested case-control study Controls for ET-to-PV cases will be patients diagnosed with ET, according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria, JAK2V617F positive who did not progress to PV after a comparable period of time. This control group will be selected using a 1:1 matched case-control design.
For each patient who progressed to PV (case), a control will be selected with the following characteristics:
- year of ET diagnosis (+/-2 years as compared to the date of the case);
- age at ET diagnosis (+/-3 years as compared to the age of the case);
- duration of ET disease (+/-2 years as compared to the period between the diagnosis of ET and the index date of the respective case).
Part B - Comparative retrospective cohort study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- ET patients (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) who are JAK2V617F positive and have progressed to PV (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) by 31/12/
- •The date of PV diagnosis will be defined as the index date and this group of patients will be defined as ET-to-PV cases.
排除标准
- 未提供
研究组 & 干预措施
ET to PV patients
Patients JAK2V617F positive and who have progressed to PV by 31/12/2020.
ET patients
Patients JAK2V617F positive who did not progress to PV after a comparable period of time. This control group will be selected using a 1:1 matched case-control design.
PV de novo patients
Patients diagnosed with de novo PV (no progression from previous ET). This control group will be recruited using a 1:1 matching procedure.
结局指标
主要结局
Nested case-control study
时间窗: Up to the baseline
To identify proliferative risk factors for progression from ET to PV in JAK2V617F positive patients.
Comparative retrospective cohort study
时间窗: Up to the baseline
To evaluate the different disease prognosis in ET patients who have progressed to PV compared to de novo PV patients.
次要结局
- Nested case-control study(At the time of progression)
- Comparative retrospective cohort study(At the time of progression)