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临床试验/NCT05686447
NCT05686447招募中不适用

Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis

Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
M-protein

研究概览

简要总结

To provide a comprehensive MALDI-TOF mass spectrometry method for detecting, characterizing, and quantifying M-protein, and to track M-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment.

详细描述

M-protein is a serum biomarker directly related to clonal plasma cell load in Multiple myeloma (MM) patients and can be used as a diagnostic marker to make out disease and a quantitative marker to track disease progression and response to treatment. Identification, typing and quantification of M-proteins are useful for initial diagnosis of disease, risk stratification and monitoring of response to treatment. Although the determination of M-protein can be used as an auxiliary diagnosis of multiple myeloma, the early diagnosis and risk assessment of MM still lack convenient and effective tools for large-scale screening. In recent years, the use of matter-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) for proteomic analysis of complex biological mixtures has attracted extensive attention, and has become one of the most promising methods for the detection of m proteins. In this study, we screened the population by MALDI mass spectrometry in order to detect low level circulating M-protein by a faster and more sensitive method.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • (1) Inclusion criteria for cases: Serum samples from related people diagnosed with multiple myeloma were included in MALDI-TOF-MS analysis by serum protein electrophoresis (SPEP), serum immunofixation electrophoresis (IFE), Ig isotype detection and other methods. (2) Inclusion criteria of the controls were as follows: individuals in good health without obvious disease and with normal physical examination report; Avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex.

排除标准

  • samples with incomplete sample information and untraceable source; Samples whose sample volume is insufficient for testing; Samples that do not meet the requirements for sample collection and storage

结局指标

主要结局

M-protein

时间窗: baseline

M-protein in urine and serum detected using MALDI-TOF Mass Spectrometry

次要结局

未报告次要终点

研究者

发起方
Zhujiang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongwei Zhou

Professor

Zhujiang Hospital

研究点 (1)

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