Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Multiple myeloma 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. |
Other: Observational studies, no intervention
Observational studies, no intervention
|
| Healthy control 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. |
Other: Observational studies, no intervention
Observational studies, no intervention
|
Outcome Measures
Primary Outcome Measures
- M-protein [baseline]
M-protein in urine and serum detected using MALDI-TOF Mass Spectrometry
Eligibility Criteria
Criteria
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.
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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
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Zhujiang Hospital
- National Natural Science Foundation of China
Investigators
- Study Chair: Hongwei Zhou, Professor, Zhujiang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Zhujianghjd