This study aims to utilize a highly sensitive method for detecting M protein in serum toexamine the prevalence of M protein in various age groups of individuals aged over 30 whounderwent physical examinations in different regions of China. Furthermore, the studyseeks to analyze the relationship between physical examination indicators and thepresence of serum M protein (as measured by relative intensity) in the study participantsat the time of enrollment. Additionally, a 5-year follow-up period will be employed toobserve the association between annual physical examination indicators and clinicaloutcomes in subjects identified with positive/negative serum M protein screening.
Monoclonal gammopathy (MG) is an asymptomatic premalignant clonal proliferation of plasma
cells. The onset of this condition is typically concealed and often serendipitously
discovered by patients through various clinical symptoms or the detection of monoclonal
gamma globulin (M protein) using protein electrophoresis during disease evaluation.
Although monoclonal gammopathy of unknown significance (MGUS) usually remains
asymptomatic, it can progress to multiple myeloma (MM) over time. With the aging
population, the prevalence of MGUS continues to rise among the general population.
Therefore, it is crucial to screen individuals over the age of 50, or even younger, for
serum M protein.
Currently, the investigators have established a highly sensitive and high-throughput
flight mass spectrometry-based method for detecting M protein. In this study, the
investigators aim to conduct a nationwide, multicenter, and prospective follow-up study
involving participants from the general physical examination population. The study's
objective is to investigate the epidemiological characteristics of targeted serum M
protein screening for precancerous lesions in multiple myeloma. The investigators will
assess the proportion of individuals with positive serum M protein in different age
groups within the physical examination population aged over 30 from various regions in
China. Additionally, the investigators will analyze the correlation between physical
examination indicators such as liver and kidney function and the presence of serum M
protein. Furthermore, the investigators will analyze the relationship between serum M
protein levels, disease progression, and other clinical outcomes through annual follow-up
assessments.
Diagnostic Test: Serum M protein screening
Using highly sensitivity test to screen serum M protein of all participants.
Inclusion Criteria:
(1) Screening stage
1. Over 30 years old.
2. Volunteer to participate in this study and sign an informed consent form.
(2) Follow up stage
1. According to previous studies, a positive rate of 5% -8% was found in subjects with
positive M protein screening. Each sub center included approximately 50-80 positive
subjects based on actual conditions. At the same time, control subjects with
negative M protein testing were matched by age and gender parameter 1:1.
2. Volunteer to participate in the follow-up phase of the study and sign an informed
consent form.
Exclusion Criteria:
(1) Screening stage
1) Previously diagnosed with hematological diseases such as plasma cell or other B
lymphocyte proliferative diseases.
Culling criteria:
1. Samples with incomplete or untraceable subject data.
2. Unqualified samples: including serum samples with severe hemolysis, fatty blood or
jaundice, insufficient sample, and samples not stored as required.
3. The subject requested to withdraw from the study midway.
4. Duplicate samples of subjects at the same time point.
Not Provided
Nianyi Zeng
13928801657 - +86
zengny1@i.smu.edu.cn
Hongwei Zhou, Professor
18688489622 - +86
hzhou@smu.edu.cn
Hongwei Zhou, Professor, Study Chair
Zhujiang Hospital