NCT06489613

Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15,600 (estimated)
• Sponsor: Jian Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• M Protein
• Monoclonal Gammopathy
• Monoclonal Gammopathy of Undetermined Significance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	M protein detection by iMS-LC Assay	iMS-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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2024-07-08
• Last updated: 2024-07-09

Locations

1 site across 1 country: China