Development of a Blood Score for Myelofibrosis Staging in BCR:ABL1 Negative Myeloproliferative Neoplasms Using Bone Marrow Biopsy as a Gold Standard
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Area under the curve
研究概览
简要总结
BCR:ABL1 negative myeloproliferative neoplasms (MPN) include three entities: polycythemia vera, essential thrombocythemia and primitive myelofibrosis. Myelofibrosis is a life-threatening complication in MPN with several therapeutic options including hematopoietic stem cell transplantation (HSCT) which remains the only curative treatment. Bone marrow biopsy with histological analysis allows myelofibrosis identification and staging. However, it is an invasive procedure that remains painful and provides potential haemorrhagic complications. Development of non-invasive biomarkers for myelofibrosis staging could help to better stratify this disease, better define patients' prognosis and lead to optimal cares.
The main aim of this work is to develop a non-invasive blood score including several biomarkers for myelofibrosis staging in MPN using bone marrow biopsy as a gold standard.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Diagnosis of BCR::ABL1 negative MPN according to WHO criteria classification
- •Indication for bone marrow biopsy
- •Non opposition
- •Social security affiliation
排除标准
- •Non-contributory biopsy
- •AML transformation
- •Organ fibrosis (liver, lung, kidney...)
- •Chronic inflammatory disease
结局指标
主要结局
Area under the curve
时间窗: At diagnosis
Area under the receiver operating characteristic (AUROC) curve of the blood score to discriminate absence or mild fibrosis from advanced fibrosis, using histological analysis as a gold standard.
次要结局
- Number of patients(Up to 2 years)