Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis
- Conditions
- Multiple MyelomaM-proteinMonoclonal Gammopathies
- Interventions
- Other: Observational studies, no intervention
- Registration Number
- NCT05686447
- Lead Sponsor
- Zhujiang Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
(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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Multiple myeloma Observational studies, no intervention Multiple myeloma (MM) is a hematologic malignant tumor characterized by abnormally cloned plasma cells in bone marrow, whose growth can lead to destructive bone injury, acute kidney injury, anemia, and hypercalcemia. Healthy control Observational studies, no intervention 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.
- Primary Outcome Measures
Name Time Method M-protein baseline M-protein in urine and serum detected using MALDI-TOF Mass Spectrometry
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China