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

Jian Li

Status

Not yet enrolling

Conditions

M Protein

Monoclonal Gammopathy

Monoclonal Gammopathy of Undetermined Significance

Treatments

Diagnostic Test: M protein detection by iMS-LC Assay

Study type

Observational

Funder types

Other

Identifiers

NCT06489613

iMS-LC Assay

Details and patient eligibility

About

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.

Enrollment

15,600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical patients:
- ≥18 years old;
- have concurrent SPEP + SIFE + FLC test results.
Individuals undergoing routine physical examinations:
- ≥30 years old;
- have concurrent SPEP test results.