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Trial Title:
Screening and Therapeutic Monitoring of Multiple Myeloma by MALDI-TOF MS Analysis
NCT ID:
NCT05686447
Condition:
Monoclonal Gammopathies
Multiple Myeloma
M-protein
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Conditions: Keywords:
M-protein
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Observational studies, no intervention
Description:
Observational studies, no intervention
Arm group label:
Healthy control
Arm group label:
Multiple myeloma
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.
Criteria for eligibility:
Study pop:
All the patients with Multiple myeloma hospitalized in Zhujiang hospital will be eligible
to be enrolled. Also, their age- and sex- matched healthy controls making a physical
examination in Zhujiang hospital will be eligible to be enrolled
Sampling method:
Non-Probability Sample
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.
- 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
-
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongwei Zhou, Professor
Phone:
18688489622
Email:
hzhou@smu.edu.cn
Start date:
January 1, 2023
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Collaborator:
Agency:
National Natural Science Foundation of China
Agency class:
Other
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05686447
