A Cross-sectional Study on the Positive Rate of M Protein Based on a Highly Sensitive Serum M Protein Detection Method.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Multiple Myeloma, M Protein

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Patients attending the outpatient/emergency/inpatient department of Zhujiang Hospital; (2) Age: over 18 years old; (3) There are sufficient remaining serum samples and extensive informed consent has been signed. Exclusion Criteria: (1) Early diagnosis of hematological diseases such as plasma cell or other B lymphocyte proliferative diseases. (2) Improper storage or repeated freeze-thaw of remaining serum samples.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who come to the hospital for treatment<br>Patients attending the outpatient/emergency/inpatient department of Zhujiang Hospital over 18 years old. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive rate of M protein | Positive rate of serum M protein in patients seeking medical treatment at the hospital | one year | 
| The distribution of positive rate of M protein in different departments | The positive rate of serum M protein in the patients visiting the hospital and its distribution in different departments. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation analysis | Correlation analysis between the relative concentration of serum M protein and clinical indicators. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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M protein