NCT06082284

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

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Myeloma
• M Protein

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-04-30
• Completion: 2025-12-31
• First posted: 2023-10-13
• Last updated: 2024-12-20

Locations

1 site across 1 country: China