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

Not yet recruiting

• Conditions: M Protein; Monoclonal Gammopathy; Monoclonal Gammopathy of Undetermined Significance
• Interventions: Diagnostic Test: M protein detection by iMS-LC Assay

• Registration Number: NCT06489613
• Lead Sponsor: Jian Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Status Verified: 2024-07
• Study Start: 2024-07
• Last Update Submitted: 2024-07-06
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15600

Inclusion Criteria

1. Clinical patients:

   • ≥18 years old;
   • have concurrent SPEP + SIFE + FLC test results.

2. Individuals undergoing routine physical examinations:

   • ≥30 years old;
   • have concurrent SPEP test results.

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals undergoing routine physical examinations	M protein detection by iMS-LC Assay	Residual plasma specimens for iMS-LC Assay to detect M protein
Clinical patients	M protein detection by iMS-LC Assay	Residual plasma specimens for iMS-LC Assay to detect M protein

Primary Outcome Measures

Name	Time	Method
Diagnostic efficacy of the iMS-LC Assay	2024-07 to 2024-10	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.
Prevalence of MGUS in the population undergoing routine physical examinations	2024-07 to 2024-12	The prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China