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

NCT06489613 | Not Yet Recruiting

• 1 other identifier: iMS-LC Assay
• Study Type: observational
• Target: 15,600
• Locations: 1 country
• Sites: 1

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.

Conditions

M Protein; Monoclonal Gammopathy; Monoclonal Gammopathy of Undetermined Significance

Keywords

M protein; Monoclonal gammopathy of unknown significance

Outcome Measures

Primary Outcomes (2)

• Diagnostic efficacy of the iMS-LC Assay

  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.

  2024-07 to 2024-10

• Prevalence of MGUS in the population undergoing routine physical examinations

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

  2024-07 to 2024-12

Study Arms (2)

Clinical patients

Residual plasma specimens for iMS-LC Assay to detect M protein

Diagnostic Test: M protein detection by iMS-LC Assay

Individuals undergoing routine physical examinations

Residual plasma specimens for iMS-LC Assay to detect M protein

Diagnostic Test: M protein detection by iMS-LC Assay

Interventions

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.

Clinical patients; Individuals undergoing routine physical examinations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Clinical patients: 600 continuous outpatients/inpatients diagnosed with or suspected of having monoclonal gammopathy. 2. 15,000 continuous individuals undergoing routine physical examinations.

You may qualify if:

• 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.

Sponsors & Collaborators

• Jian Li: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (4)

• Murray DL, Puig N, Kristinsson S, Usmani SZ, Dispenzieri A, Bianchi G, Kumar S, Chng WJ, Hajek R, Paiva B, Waage A, Rajkumar SV, Durie B. Mass spectrometry for the evaluation of monoclonal proteins in multiple myeloma and related disorders: an International Myeloma Working Group Mass Spectrometry Committee Report. Blood Cancer J. 2021 Feb 1;11(2):24. doi: 10.1038/s41408-021-00408-4.

  PMID: 33563895 BACKGROUND

• Kohlhagen M, Dasari S, Willrich M, Hetrick M, Netzel B, Dispenzieri A, Murray DL. Automation and validation of a MALDI-TOF MS (Mass-Fix) replacement of immunofixation electrophoresis in the clinical lab. Clin Chem Lab Med. 2020 Aug 3;59(1):155-163. doi: 10.1515/cclm-2020-0581.

  PMID: 32745067 BACKGROUND

• Dasari S, Kohlhagen MC, Dispenzieri A, Willrich MAV, Snyder MR, Kourelis TV, Lust JA, Mills JR, Kyle RA, Murray DL. Detection of Plasma Cell Disorders by Mass Spectrometry: A Comprehensive Review of 19,523 Cases. Mayo Clin Proc. 2022 Feb;97(2):294-307. doi: 10.1016/j.mayocp.2021.07.024. Epub 2021 Dec 7.

  PMID: 34887112 BACKGROUND

• Keren DF, Bocsi G, Billman BL, Etzell J, Faix JD, Kumar S, Lipe B, McCudden C, Montgomery R, Murray DL, Rai AJ, Redondo TC, Souter L, Ventura CB, Ansari MQ. Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies. Arch Pathol Lab Med. 2022 May 1;146(5):575-590. doi: 10.5858/arpa.2020-0794-CP.

  PMID: 34347866 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Clinical residual serum samples

MeSH Terms

Conditions

Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hypergammaglobulinemia

Central Study Contacts

Jian Li

CONTACT

+86-18610852525; lijian@pumch.cn

Zihan Yang

CONTACT

+86-18800173196; yzh18800173196@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)