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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06082284

Enrollment

10000

Registered

2023-10-13

Start date

2023-10-01

Completion date

2025-12-31

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M Protein, Multiple Myeloma

Keywords

M protein

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Correlation analysis	one year	Correlation analysis between the relative concentration of serum M protein and clinical indicators.

Countries

China

Contacts

Primary ContactNianyi Zeng

zengny1@i.smu.edu.cn13928801657

Outcome results