Multi-center Screening for Serum M Protein

NCT06750965 | Not Yet Recruiting

• 1 other identifier: Zhujiang multi-center
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Monoclonal Gammopathy; Multiple Myeloma; M-protein

Keywords

M-protein

Outcome Measures

Primary Outcomes (1)

• Positive rate of serum M protein

  In the stage of enrollment of this cross-sectional study, investigate the positive rate of serum M protein in subjects of different age groups in different sub-centers across the country, and analyze the correlation between M protein positive and physical examination indicators.

  1 year

Secondary Outcomes (1)

• The correlation between serum M protein positivity and related symptoms and indicators

  Five years

Study Arms (3)

Physical examination population （Screening stage）

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

Diagnostic Test: Serum M protein screening

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.

Diagnostic Test: Serum M protein screening

Negative control subjects （Follow up stage）

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

Diagnostic Test: Serum M protein screening

Interventions

Serum M protein screening DIAGNOSTIC_TEST

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

Negative control subjects （Follow up stage）; Physical examination population （Screening stage）; Positive subjects for M-protein screening （Follow up stage）

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is a physical examination population aged over 30 and of different age groups from different regions of China. This study selected the study population as the research object based on inclusion, exclusion, and culling criteria.

You may qualify if:

• (1) Screening stage
• Over 30 years old.
• Volunteer to participate in this study and sign an informed consent form.
• (2) Follow up stage
• 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.
• Volunteer to participate in the follow-up phase of the study and sign an informed consent form.

You may not qualify if:

• (1) Screening stage
• \) Previously diagnosed with hematological diseases such as plasma cell or other B lymphocyte proliferative diseases.
• Culling criteria:
• Samples with incomplete or untraceable subject data.
• Unqualified samples: including serum samples with severe hemolysis, fatty blood or jaundice, insufficient sample, and samples not stored as required.
• The subject requested to withdraw from the study midway.
• Duplicate samples of subjects at the same time point.

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Conditions

Paraproteinemias; Multiple Myeloma

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders

Study Officials

• Hongwei Zhou, Professor

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Nianyi Zeng

CONTACT

13928801657; zengny1@i.smu.edu.cn

Hongwei Zhou, Professor

CONTACT

18688489622; hzhou@smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: December 27, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share