Monoclonal GammopathyNCT06750965
Multi-center Screening for Serum M Protein
An observational study of Monoclonal Gammopathy and Multiple Myeloma, run by Zhujiang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monoclonal Gammopathy, Multiple Myeloma, M-protein
- What is being tested?
- Serum M protein screening
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Screening stage
- Over 30 years old.
- Volunteer to participate in this study and sign an informed consent form.
- 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.
Who cannot join
- Screening stage
- 1) 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Epidemiological Characteristics Associated With Precursor Lesions of Multiple Myeloma Using Serum M Protein Screening: a Multi-center, Prospective Cohort Study.
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.
Read the 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
- Being tested
- Serum M protein screening
- Keywords
- M-protein
- Medical subject headings
- Paraproteinemias, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum M protein screeningDiagnostic test
Using highly sensitivity test to screen serum M protein of all participants.
| Study group | Role | What they receive |
|---|---|---|
| Physical examination population （Screening stage） | Subjects of different age groups in different sub-centers nationwide for physical examination Receives: 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. Receives: 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. Receives: Diagnostic Test: Serum M protein screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary 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.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal GammopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwei Zhou, Professor, Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750965
- Sponsor's protocol ID
- Zhujiang multi-center
- Status last verified
- Apr 2025
- First submitted
- 4 Jan 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Characteristics Associated With Precursor Lesions of Multiple Myeloma Using Serum M Protein Screening: a Multi-center, Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06750965
- Acronym / sponsor ID
- Zhujiang multi-center
- Conditions
- Monoclonal Gammopathy, Multiple Myeloma, M-protein
- Keywords
- M-protein
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical examination population （Screening stage） | – | Diagnostic Test: Serum M protein screeningSubjects of different age groups in different sub-centers nationwide for physical examination |
| Positive subjects for M-protein screening （Follow up stage） | – | Diagnostic Test: Serum M protein screeningEach sub-center will include subjects who are positive for M protein screening based on their actual situation. |
| Negative control subjects （Follow up stage） | – | Diagnostic Test: Serum M protein screeningEach sub-center matched control subjects with negative M protein detection by age and gender parameter 1:1. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Screening stage
- Over 30 years old.
- Volunteer to participate in this study and sign an informed consent form.
- 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.
Key exclusion criteria (7 listed)
- Screening stage
- 1) Previously diagnosed with hematological diseases such as plasma cell or other B lymphocyte proliferative diseases.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum M protein screeningUsing highly sensitivity test to screen serum M protein of all participants. | Diagnostic test | Negative control subjects （Follow up stage）, Physical examination population （Screening stage）, Positive subjects for M-protein screening （Follow up stage） |
Primary outcome
Positive rate of serum M protein
Time frame: 1 year
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 secondary outcome
The correlation between serum M protein positivity and related symptoms and indicators
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongwei Zhou, Professor study chair
Zhujiang Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal Gammopathy and Multiple Myeloma, run by Zhujiang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nianyi Zeng (13928801657 ext. +86, zengny1@i.smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive rate of serum M protein (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.