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

NCT ID: NCT05686447

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-07-31

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.

Conditions

Monoclonal Gammopathies; Multiple Myeloma; M-protein

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

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.

Observational studies, no intervention

Intervention Type: OTHER

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.

Observational studies, no intervention

Intervention Type: OTHER

Observational studies, no intervention

Interventions

Observational studies, no intervention

Observational studies, no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hongwei Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongwei Zhou, Professor

Role: STUDY_CHAIR

Zhujiang Hospital

Locations

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Nianyi Zeng

Role: CONTACT

zengny1@i.smu.edu.cn

13928801657 ext. +86

Hongwei Zhou, Professor

Role: CONTACT

hzhou@smu.edu.cn

18688489622 ext. +86

Facility Contacts

Hongwei Zhou, Professor

Role: primary

hzhou@smu.edu.cn

18688489622

Other Identifiers

Zhujianghjd

Identifier Type: -

Identifier Source: org_study_id