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

Multiple Myeloma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082284
• Other study ID #: Zhujiangzny
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Zhujiang Hospital
• Contact: Nianyi Zeng
• Phone: 13928801657
• Email: zengny1[@]i.smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Multiple Myeloma

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive rate of M protein	Positive rate of serum M protein in patients seeking medical treatment at the hospital	one year
Primary	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	Correlation analysis	Correlation analysis between the relative concentration of serum M protein and clinical indicators.	one year