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

December 17, 2024 updated by: Zhujiang Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nianyi Zeng
Phone Number: +86 13928801657
Email: zengny1@i.smu.edu.cn

Study Locations

China
- Guangdong
  - Guangzhou, Guangdong, China, 510280
    - Recruiting
    - ZhuJiang Hospital of Southern Medical University
    - Contact:
      
      Hongwei Zhou, Professor
      
      Phone Number: +86 18688489622
      
      Email: hzhou@smu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years old attending the outpatient/emergency/inpatient departments of Zhujiang Hospital, including departments such as hematology, general surgery, dermatology, and others.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Patients who come to the hospital for treatment Patients attending the outpatient/emergency/inpatient department of Zhujiang Hospital over 18 years old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of M protein Time Frame: one year	Positive rate of serum M protein in patients seeking medical treatment at the hospital	one year
The distribution of positive rate of M protein in different departments Time Frame: one year	The positive rate of serum M protein in the patients visiting the hospital and its distribution in different departments.	one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

Study Chair: Hongwei Zhou, Professor, Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria