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Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis

Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05686447
Enrollment
200
Registered
2023-01-17
Start date
2023-01-01
Completion date
2026-07-31
Last updated
2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monoclonal Gammopathies, M-protein, Multiple Myeloma

Keywords

M-protein

Brief summary

To provide a comprehensive MALDI-TOF mass spectrometry method for detecting, characterizing, and quantifying M-protein, and to track M-protein in a very sensitive and specific manner during patient treatment, providing a more precise test for diagnosing disease and monitoring patient response to treatment.

Detailed description

M-protein is a serum biomarker directly related to clonal plasma cell load in Multiple myeloma (MM) patients and can be used as a diagnostic marker to make out disease and a quantitative marker to track disease progression and response to treatment. Identification, typing and quantification of M-proteins are useful for initial diagnosis of disease, risk stratification and monitoring of response to treatment. Although the determination of M-protein can be used as an auxiliary diagnosis of multiple myeloma, the early diagnosis and risk assessment of MM still lack convenient and effective tools for large-scale screening. In recent years, the use of matter-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) for proteomic analysis of complex biological mixtures has attracted extensive attention, and has become one of the most promising methods for the detection of m proteins. In this study, we screened the population by MALDI mass spectrometry in order to detect low level circulating M-protein by a faster and more sensitive method.

Interventions

Observational studies, no intervention

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Zhujiang Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

(1) Inclusion criteria for cases: Serum samples from related people diagnosed with multiple myeloma were included in MALDI-TOF-MS analysis by serum protein electrophoresis (SPEP), serum immunofixation electrophoresis (IFE), Ig isotype detection and other methods. (2) Inclusion criteria of the controls were as follows: individuals in good health without obvious disease and with normal physical examination report; Avoid people who have not suffered from major chronic diseases in recent years, such as hypertension, diabetes, chronic kidney disease, etc; controls were appropriately selected that matched cases for age and sex. \-

Exclusion criteria

samples with incomplete sample information and untraceable source; Samples whose sample volume is insufficient for testing; Samples that do not meet the requirements for sample collection and storage \-

Design outcomes

Primary

MeasureTime frameDescription
M-proteinbaselineM-protein in urine and serum detected using MALDI-TOF Mass Spectrometry

Countries

China

Contacts

Primary ContactNianyi Zeng
zengny1@i.smu.edu.cn13928801657
Backup ContactHongwei Zhou, Professor
hzhou@smu.edu.cn18688489622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026