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This study aims to utilize a highly sensitive method for detecting M protein in serum to examine the prevalence of M protein in various age groups of individuals aged over 30 who underwent physical examinations in different regions of China. Furthermore, the study seeks to analyze the relationship between physical examination indicators and the presence of serum M protein (as measured by relative intensity) in the study participants at the time of enrollment. Additionally, a 5-year follow-up period will be employed to observe the association between annual physical examination indicators and clinical outcomes 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical examination population (Screening stage) | Subjects of different age groups in different sub-centers nationwide for physical examination |
| |
| Positive subjects for M-protein screening (Follow up stage) | Each sub-center will include subjects who are positive for M protein screening based on their actual situation. |
| |
| Negative control subjects (Follow up stage) | Each sub-center matched control subjects with negative M protein detection by age and gender parameter 1:1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum M protein screening | Diagnostic Test | Using highly sensitivity test to screen serum M protein of all participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive rate of serum M protein | In the stage of enrollment of this cross-sectional study, investigate the positive rate of serum M protein in subjects of different age groups in different sub-centers across the country, and analyze the correlation between M protein positive and physical examination indicators. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation between serum M protein positivity and related symptoms and indicators | At every follow-up time points, to observe the correlation between serum M protein positivity and related symptoms and indicators. | Five years |
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Inclusion Criteria:
(1) Screening stage
(2) Follow up stage
Exclusion Criteria:
(1) Screening stage
1) Previously diagnosed with hematological diseases such as plasma cell or other B lymphocyte proliferative diseases.
Culling criteria:
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The study population is a physical examination population aged over 30 and of different age groups from different regions of China. This study selected the study population as the research object based on inclusion, exclusion, and culling criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nianyi Zeng | Contact | 13928801657 | +86 | zengny1@i.smu.edu.cn |
| Hongwei Zhou, Professor | Contact | 18688489622 | +86 | hzhou@smu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongwei Zhou, Professor | Zhujiang Hospital | Study Chair |
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| ID | Term |
|---|---|
| D010265 | Paraproteinemias |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |