Clinical trial · Observational
Multi-center Screening for Serum M Protein
Epidemiological Characteristics Associated With Precursor Lesions of Multiple Myeloma Using Serum M Protein Screening: a Multi-center, Prospective Cohort Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Monoclonal Gammopathy | — | UNRESOLVED | — |
| M-protein | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serum M protein screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Physical examination population （Screening stage）
- description
- Subjects of different age groups in different sub-centers nationwide for physical examination
- interventionNames
- Diagnostic Test: Serum M protein screening
- label
- Positive subjects for M-protein screening （Follow up stage）
- description
- Each sub-center will include subjects who are positive for M protein screening based on their actual situation.
- interventionNames
- Diagnostic Test: Serum M protein screening
- label
- Negative control subjects （Follow up stage）
- description
- Each sub-center matched control subjects with negative M protein detection by age and gender parameter 1:1.
- interventionNames
- Diagnostic Test: Serum M protein screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
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