Multi-center Screening for Serum M Protein

NCT ID: NCT06750965

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2029-12-31

Brief Summary

This study aims to utilize a highly sensitive method for detecting M protein in serum to examine the prevalence of M protein in various age groups of individuals aged over 30 who underwent physical examinations in different regions of China. Furthermore, the study seeks to analyze the relationship between physical examination indicators and the presence of serum M protein (as measured by relative intensity) in the study participants at the time of enrollment. Additionally, a 5-year follow-up period will be employed to observe the association between annual physical examination indicators and clinical outcomes in subjects identified with positive/negative serum M protein screening.

Detailed Description

Monoclonal gammopathy (MG) is an asymptomatic premalignant clonal proliferation of plasma cells. The onset of this condition is typically concealed and often serendipitously discovered by patients through various clinical symptoms or the detection of monoclonal gamma globulin (M protein) using protein electrophoresis during disease evaluation. Although monoclonal gammopathy of unknown significance (MGUS) usually remains asymptomatic, it can progress to multiple myeloma (MM) over time. With the aging population, the prevalence of MGUS continues to rise among the general population. Therefore, it is crucial to screen individuals over the age of 50, or even younger, for serum M protein.

Currently, the investigators have established a highly sensitive and high-throughput flight mass spectrometry-based method for detecting M protein. In this study, the investigators aim to conduct a nationwide, multicenter, and prospective follow-up study involving participants from the general physical examination population. The study's objective is to investigate the epidemiological characteristics of targeted serum M protein screening for precancerous lesions in multiple myeloma. The investigators will assess the proportion of individuals with positive serum M protein in different age groups within the physical examination population aged over 30 from various regions in China. Additionally, the investigators will analyze the correlation between physical examination indicators such as liver and kidney function and the presence of serum M protein. Furthermore, the investigators will analyze the relationship between serum M protein levels, disease progression, and other clinical outcomes through annual follow-up assessments.

Conditions

Monoclonal Gammopathy; Multiple Myeloma; M-protein

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Physical examination population （Screening stage）

Subjects of different age groups in different sub-centers nationwide for physical examination

Serum M protein screening

Intervention Type: DIAGNOSTIC_TEST

Using highly sensitivity test to screen serum M protein of all participants.

Positive subjects for M-protein screening （Follow up stage）

Each sub-center will include subjects who are positive for M protein screening based on their actual situation.

Serum M protein screening

Intervention Type: DIAGNOSTIC_TEST

Using highly sensitivity test to screen serum M protein of all participants.

Negative control subjects （Follow up stage）

Each sub-center matched control subjects with negative M protein detection by age and gender parameter 1:1.

Serum M protein screening

Intervention Type: DIAGNOSTIC_TEST

Using highly sensitivity test to screen serum M protein of all participants.

Interventions

Serum M protein screening

Using highly sensitivity test to screen serum M protein of all participants.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

(1) Screening stage

1. Over 30 years old.

2. Volunteer to participate in this study and sign an informed consent form.

(2) Follow up stage

1. According to previous studies, a positive rate of 5% -8% was found in subjects with positive M protein screening. Each sub center included approximately 50-80 positive subjects based on actual conditions. At the same time, control subjects with negative M protein testing were matched by age and gender parameter 1:1.

2. Volunteer to participate in the follow-up phase of the study and sign an informed consent form.

Exclusion Criteria

(1) Screening stage

1) Previously diagnosed with hematological diseases such as plasma cell or other B lymphocyte proliferative diseases.

Culling criteria:

1. Samples with incomplete or untraceable subject data.

2. Unqualified samples: including serum samples with severe hemolysis, fatty blood or jaundice, insufficient sample, and samples not stored as required.

3. The subject requested to withdraw from the study midway.

4. Duplicate samples of subjects at the same time point.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongwei Zhou, Professor

Role: STUDY_CHAIR

Zhujiang Hospital

Central Contacts

Nianyi Zeng

Role: CONTACT

zengny1@i.smu.edu.cn

13928801657 ext. +86

Hongwei Zhou, Professor

Role: CONTACT

hzhou@smu.edu.cn

18688489622 ext. +86

Other Identifiers

Zhujiang multi-center

Identifier Type: -

Identifier Source: org_study_id