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临床试验/NCT06082284
NCT06082284招募中不适用

A Cross-sectional Study on the Positive Rate of Monoclonal Immunoglobulin (M Protein) in the Serum of Patients Seeking Medical Treatment in Tertiary Hospitals Based on a Highly Sensitive Serum M Protein Detection Method.

Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2023年10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
10,000
试验地点
1
主要终点
Positive rate of M protein

研究概览

简要总结

By using a highly sensitive serum M protein detection method based on the MALDI-TOF MS platform, serum monoclonal immunoglobul (M protein) in detection was performed on the visiting patients to explore the positive rate of serum M protein and its distribution in different departments. And exploring the correlation analysis between the relative concentration of serum M protein based on the above highly sensitive methods and clinical indicators.

详细描述

Monoclonal gammopathy (MG) is an asymptomatic pre-cancerous clonal proliferation of plasma cells. The onset of this disease is concealed, usually discovered by chance by patients who undergo protein electrophoresis to detect monoclonal gamma globulin (M protein) due to various clinical symptoms and disease evaluations. Due to the insidious onset of monoclonal immunoglobulin, involving multiple organs, and the non-specific clinical symptoms, it is more prone to misdiagnosis. This study hypothesized that among patients who first came to the hospital for treatment, some patients had elevated serum monoclonal immunoglobulin levels but were not initially diagnosed with hematology department, but instead sought medical attention from other departments due to other symptoms. In this study,by using a highly sensitive serum M protein detection method based on the MALDI-TOF MS platform, serum monoclonal immunoglobul (M protein) in detection was performed on the visiting patients to explore the positive rate of serum M protein and its distribution in different departments,and to explore the correlation analysis between the relative concentration of serum M protein based on the above highly sensitive methods and clinical indicators.

研究设计

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

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

  • Patients attending the outpatient/emergency/inpatient department of Zhujiang Hospital;
  • Age: over 18 years old;
  • There are sufficient remaining serum samples and extensive informed consent has been signed.

排除标准

  • Early diagnosis of hematological diseases such as plasma cell or other B lymphocyte proliferative diseases;
  • Improper storage or repeated freeze-thaw of remaining serum samples.

结局指标

主要结局

Positive rate of M protein

时间窗: one year

Positive rate of serum M protein in patients seeking medical treatment at the hospital

The distribution of positive rate of M protein in different departments

时间窗: one year

The positive rate of serum M protein in the patients visiting the hospital and its distribution in different departments.

次要结局

  • Correlation analysis(one year)

研究者

发起方
Zhujiang Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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