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

Recruiting

• Conditions: M Protein; Multiple Myeloma

• Registration Number: NCT06082284
• Lead Sponsor: Zhujiang Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive rate of M protein	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	one year	The positive rate of serum M protein in the patients visiting the hospital and its distribution in different departments.

Secondary Outcome Measures

Name	Time	Method
Correlation analysis	one year	Correlation analysis between the relative concentration of serum M protein and clinical indicators.

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China