Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJian Li
About this trial
iMS-LC Assay (intact M-protein Screening-Light Chain Assay) is a new technology based on mass spectrometry identification of intact clonal immunoglobulin light chains for the specific detection of M-proteins in peripheral blood.
The investigators propose to conduct a prospective, single-center observational study to screen for M-proteins in the peripheral blood of individuals undergoing routine physical examinations using iMS-LC Assay technology. The goals of this observational study are : (1) to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins using the iMS-LC Assay method; and (2) to determine the prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.
Initially, the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the iMS-LC Assay, using the clinical methods SPEP + SIFE + FLC as the gold standard. Based on the diagnostic performance of the iMS-LC Assay, the investigators will then screen for M-proteins in continuous samples from individuals undergoing routine physical examinations, to further determine the prevalence of MGUS in this population based on mass spectrometry screening.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old;
have concurrent SPEP + SIFE + FLC test results.
≥30 years old;
have concurrent SPEP test results.
Disqualifiers
NA
Trial population
1. Clinical patients: 600 continuous outpatients/inpatients diagnosed with or suspected of having monoclonal gammopathy. 2. 15,000 continuous individuals undergoing routine physical examinations.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
M protein detection by iMS-LC Assay
Diagnostic testiMS-LC Assay (intact M-protein Screening-Light Chain Assay) technology is a new method for the specific identification of M-proteins in peripheral blood, based on mass spectrometry recognition of intact clonal immunoglobulin light chains. Combined with AI algorithm models, M-proteins can be easily distinguished from the polyclonal background, enabling automated identification and quantitative analysis of M-proteins. Previous studies have shown that the detection limit of the iMS-LC Assay is several times higher than that of IFE. Additionally, the iMS-LC Assay requires only 5 μL of peripheral blood serum for detection, offering advantages over traditional methods in terms of higher sensitivity, non-invasiveness, lower sample volume requirements, reduced detection costs, and higher throughput.
Treatment groups
15,600 Participants
are divided into 2 treatment groupsGroup A: Clinical patients1 intervention
Group B: Individuals undergoing routine physical examinations1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic efficacy of the iMS-LC Assay
Using any positive result from SPEP + SIFE + FLC as the gold standard, we will obtain the diagnostic performance parameters of the iMS-LC Assay for M-protein detection, including sensitivity, specificity, kappa value, likelihood ratio, and predictive values.
Time frame
2024-07 to 2024-102
Prevalence of MGUS in the population undergoing routine physical examinations
The prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.
Time frame
2024-07 to 2024-12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jian Li
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov
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