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

Not yet recruitingOBSERVATIONAL
Enrollment

15,600

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

June 30, 2025

Conditions
M ProteinMonoclonal GammopathyMonoclonal Gammopathy of Undetermined Significance
Interventions
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."

Trial Locations (1)

100730

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

Jian Li

OTHER

NCT06489613 - Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology. | Biotech Hunter | Biotech Hunter