Development of a Peripheral Blood Assay to Replace BM Evaluation in Cytopenia - a Multi-Center Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Diagnostic accuracy of scRNAseq of peripheral blood CD34 cells in the diagnosis of cytopenia
研究概览
简要总结
This study aims to validate a novel, non-invasive diagnostic approach for blood and bone marrow malignancies using single-cell RNA sequencing of circulating hematopoietic stem and progenitor cells (cHSPCs) from peripheral blood. Building on prior work defining normal cHSPC profiles in healthy individuals, the study introduces a pipeline for identifying blood pathologies, with a focus on improving the diagnosis and subclassification of myelodysplastic syndromes (MDS). A multi-center clinical trial is proposed to evaluate the method's ability to predict bone marrow results in patients with cytopenia, potentially reducing reliance on bone marrow biopsies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Platelets < 150 × 109/L or
- •Absolute neutrophil count < 1.8 × 109/L or
- •Hemoglobin (Hgb) < 13 g/dL (males) and < 12 g/dL (female) and
- •For all genders, no evidence of Iron, folinic acid, or B12 deficiency
- •All subjects should be referred for BM analysis
排除标准
- •Previous diagnosis of leukemia (AML, MPN, ALL, CLL, MGUS/MM or any other gammopathy)
- •Lymphocytes>5000/ul
- •If patients are recruited after
- •Diagnosis of any disease related therapy 3 month prior to enrollment
结局指标
主要结局
Diagnostic accuracy of scRNAseq of peripheral blood CD34 cells in the diagnosis of cytopenia
时间窗: Three months following the peripheral blood sample
The accuracy of scRNA-seq analysis of peripheral blood CD34-positive cells, together with machine learning algorithms, will be compared with that of bone marrow sampling in cytopenia patients, in order to further validate the reference model that was recently published (https://www.nature.com/articles/s41591-025-03716-5). Among the parameters that will be compared are the diagnosis, blast count, and mutational data
次要结局
未报告次要终点