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NCT Number: NCT05686447

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Hongwei Zhou, Professor

CONTACT

[email protected]

18688489622

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Observational studies, no intervention

Other

Observational studies, no intervention

Primary outcomes

  1. M-protein

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hongwei Zhou, Professor

CONTACT

[email protected]

18688489622 ext. +86

Nianyi Zeng

CONTACT

[email protected]

13928801657 ext. +86

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 17, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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