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临床试验/NCT06302699
NCT06302699招募中不适用

Clinical Utility of Ultrasensitive Chromosomal Aberrations Detection (UCAD) for Detecting Minimal Residual Disease (MRD) and Monitoring Clonal Evolution by Low-Pass Whole Genome Sequencing in Multiple Myeloma

Institute of Hematology & Blood Diseases Hospital, China0 个研究点目标入组 80 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
主要终点
Detection of copy number variation

研究概览

简要总结

The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects diagnosed with MM.
  • With available baseline and sequential next-generation flow-MRD data.

排除标准

  • Subjects without baseline and sequential next-generation flow-MRD data.

结局指标

主要结局

Detection of copy number variation

时间窗: From May 1, 2023 to December 31, 2023

次要结局

  • Serial monitoring of treatment response(From January 1, 2024 to May 31, 20224)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gang An

Professor

Institute of Hematology & Blood Diseases Hospital, China

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