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NCT Number: NCT06489613

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

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.

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Key information

Conditions

M Protein Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Monoclonal Gammopathy Monoclonal Gammopathy of Undetermined Significance Paraproteinemias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • NA

Treatment and study plan

M protein detection by iMS-LC Assay

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic efficacy of the iMS-LC Assay

    Time frame: 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.

  2. Prevalence of MGUS in the population undergoing routine physical examinations

    Time frame: 2024-07 to 2024-12

    The prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Li

CONTACT

[email protected]

+86-18610852525

Zihan Yang

CONTACT

[email protected]

+86-18800173196

Sponsors and collaborators

Lead sponsor

Jian Li

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 8, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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