Multi-center Screening for Serum M Protein
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30+
SponsorZhujiang Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Over 30 years old.
Volunteer to participate in this study and sign an informed consent form.
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Serum M protein screening
Diagnostic testUsing highly sensitivity test to screen serum M protein of all participants.
Treatment groups
10,000 Participants
are divided into 3 treatment groupsGroup A: Physical examination population （Screening stage）1 intervention
Group B: Positive subjects for M-protein screening （Follow up stage）1 intervention
Group C: Negative control subjects （Follow up stage）1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
The correlation between serum M protein positivity and related symptoms and indicators
At every follow-up time points, to observe the correlation between serum M protein positivity and related symptoms and indicators.
Time frame
Five yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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