Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15,600
- 试验地点
- 1
- 主要终点
- Diagnostic efficacy of the iMS-LC Assay
研究概览
简要总结
iMS-LC Assay (intact M-protein Screening-Light Chain Assay) is a new technology based on mass spectrometry identification of intact clonal immunoglobulin light chains for the specific detection of M-proteins in peripheral blood.
The investigators propose to conduct a prospective, single-center observational study to screen for M-proteins in the peripheral blood of individuals undergoing routine physical examinations using iMS-LC Assay technology. The goals of this observational study are : (1) to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins using the iMS-LC Assay method; and (2) to determine the prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.
Initially, the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the iMS-LC Assay, using the clinical methods SPEP + SIFE + FLC as the gold standard. Based on the diagnostic performance of the iMS-LC Assay, the investigators will then screen for M-proteins in continuous samples from individuals undergoing routine physical examinations, to further determine the prevalence of MGUS in this population based on mass spectrometry screening.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical patients:
- •≥18 years old;
- •have concurrent SPEP + SIFE + FLC test results.
- •Individuals undergoing routine physical examinations:
- •≥30 years old;
- •have concurrent SPEP test results.
排除标准
- 未提供
结局指标
主要结局
Diagnostic efficacy of the iMS-LC Assay
时间窗: 2024-07 to 2024-10
Using any positive result from SPEP + SIFE + FLC as the gold standard, we will obtain the diagnostic performance parameters of the iMS-LC Assay for M-protein detection, including sensitivity, specificity, kappa value, likelihood ratio, and predictive values.
Prevalence of MGUS in the population undergoing routine physical examinations
时间窗: 2024-07 to 2024-12
The prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.
次要结局
未报告次要终点
研究者
Jian Li
Professor
Peking Union Medical College Hospital