Clinical and Molecular Epidemiology of Myeloproliferative Neoplasms (MPNs)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
The mandate of this MPN registry is to collect clinical information, including molecular results, from consenting patients with a variety of MPNs at different time points during the course of their disease.
详细描述
The myeloproliferative neoplasms (MPNs) are a group of rare hematological malignancies in which the bone marrow cells that produce the body's blood cells develop and function abnormally.
Despite the gains that have already been made in understanding and treatment of MPNs there is much that can still be learned. This registry will establish a clinical annotation database would help to better understand this group of diseases and to more effectively assign individual patients to the optimal therapy and so, improve their outcomes. This project will provide new insights on the molecular profiling of patients with MPN. It will be used as future resource for observational studies related to MPN.
The registry involves the collection of clinical information from patients with diagnosis of MPN at different time points during the course of their disease. The clinical data is collected following written informed consent from the Hematologic Malignancy tissue bank (UHN REB 01-0573C).
Data collected includes: a range of clinical measures, disease-associated factors, details of treatment and its results, complications during treatment, molecular and cytogenetic data, symptom assessment and survival outcome (up to 10 years).
Data will be collected prospectively and retrospectively, in both cases after obtaining written informed consent as per the study standard operating procedure (SOP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of one of the following myeloproliferative neoplasms (MPNs):
- •Atypical CML (aCML)
- •Chronic eosinophilic leukemia-not otherwise specified (CEL, NOS),
- •Chronic myelomonocytic leukemia (CMML)
- •Chronic neutrophilic leukemia (CNL),
- •Essential thrombocythemia (ET),
- •Juvenile myelomonocytic leukemia (JMML),
- •Mastocytosis, MPN unclassifiable
- •MPN/MDS unclassifiable,
- •Primary myelofibrosis (PMF),
- •Post-essential thrombocythemia myelofibrosis (post-ET MF),
- •Post-polycythemia vera MF (post-PV MF)
- •Refractory anemia with ringed sideroblasts associated with marked thrombocytosis (RARS-T)
排除标准
- 未提供
结局指标
主要结局
Survival
时间窗: Annually or at the time of transformation of disease, up to 10 years
Survival of patients with MPN
次要结局
- General patient characteristics will be captured from the Hematologic Malignancy tissue bank(Annually or at the time of transformation of disease, up to 10 years)
- MPN treatment type received(Annually or at the time of transformation of disease, up to 10 years)
- Transfusion dependence status(Annually or at the time of transformation of disease, up to 10 years)
- Disease risk score(Annually or at the time of transformation of disease, up to 10 years)
- Identifying MPN driver mutations by using next generation sequencing.(Annually or at the time of transformation of disease, up to 10 years)
- Co-morbidities(Annually or at the time of transformation of disease, up to 10 years)
- Family history of MPN will be obtained from the patient record.(Annually or at the time of transformation of disease, up to 10 years)
- Quality of life - Neoplasm Symptom(Annually or at the time of transformation of disease, up to 10 years)
- Physical symptoms of MPN(Annually or at the time of transformation of disease, up to 10 years)
- Bone marrow transplant complications (if received)(Annually or at the time of transformation of disease, up to 10 years)
- Current Blood Work(Annually or at the time of transformation of disease, up to 10 years)
- Bone marrow transplant details (if received)(Annually or at the time of transformation of disease, up to 10 years)
- Portal hypertension(Annually or at the time of transformation of disease, up to 10 years)
- Pulmonary hypertension(Annually or at the time of transformation of disease, up to 10 years)
- Thrombosis(Annually or at the time of transformation of disease, up to 10 years)
- Disease progression(Annually or at the time of transformation of disease, up to 10 years)