NCT05686447

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Monoclonal Gammopathies
• Multiple Myeloma
• M-protein

Interventions

Type	Name	Description
OTHER	Observational studies, no intervention	Observational studies, no intervention

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-06-01
• Completion: 2026-07-31
• First posted: 2023-01-17
• Last updated: 2025-04-06

Locations

1 site across 1 country: China