Clinical trial NCT06489613: Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.
Official title: Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: M Protein
Monoclonal Gammopathy
Monoclonal Gammopathy of Undetermined Significance
Keywords: M protein
Monoclonal gammopathy of unknown significance
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 15600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic efficacy of the iMS-LC Assay
timeFrame: 2024-07 to 2024-10
measure: Prevalence of MGUS in the population undergoing routine physical examinations
timeFrame: 2024-07 to 2024-12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.