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

Zhujiang Hospital

Status: Enrolling

Conditions: Multiple Myeloma; M Protein

Study type: Observational

Funder types: Other

Identifiers

NCT06082284

Zhujiangzny

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10,000 participants in 1 patient group

Patients who come to the hospital for treatment

Description:

Patients attending the outpatient/emergency/inpatient department of Zhujiang Hospital over 18 years old.