Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 290
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
Study on Early Screening of Myeloma Based on Liquid Biopsy cfDNA Fragmentomics Technology. This study aims to construct and validate a set of machine learning models for the early screening of myeloma tailored to the Chinese population, based on plasma cfDNA fragmentomics features, to effectively distinguish myeloma patients from healthy individuals.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 40 years.
- •Diagnosed with MM, SMM, or MGUS through standard diagnostic procedures.
- •Voluntarily participating and signed written informed consent.
排除标准
- •Pregnant or lactating women.
- •Prior cancer diagnosis within the past 5 years, or history of any form of systemic cancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.).
- •History of organ transplantation, or allogeneic bone marrow or stem cell transplantation.
- •History of blood transfusion within 7 days prior to blood collection.
- •Poor compliance or potential interference with signing informed consent as judged by the investigator, or any other conditions rendering the subject unsuitable for the study.
结局指标
主要结局
Sensitivity and Specificity
时间窗: Baseline
The early screening model will be developed using the training set; its sensitivity and specificity will then be evaluated in the validation set based on the consistency between the model's classification and clinical diagnosis.
次要结局
未报告次要终点
研究者
Lei Fan
Chief Physician, Professor, Ph.D. Supervisor, Director of the Department of Hematology
The First Affiliated Hospital with Nanjing Medical University