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Trial Title:
A Cross-sectional Study on the Positive Rate of M Protein Based on a Highly Sensitive Serum M Protein Detection Method.
NCT ID:
NCT06082284
Condition:
Multiple Myeloma
M Protein
Conditions: Official terms:
Multiple Myeloma
Hypersensitivity
Conditions: Keywords:
M protein
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Summary:
By using a highly sensitive serum M protein detection method based on the MALDI-TOF MS
platform, serum monoclonal immunoglobul (M protein) in detection was performed on the
visiting patients to explore the positive rate of serum M protein and its distribution in
different departments. And exploring the correlation analysis between the relative
concentration of serum M protein based on the above highly sensitive methods and clinical
indicators.
Detailed description:
Monoclonal gammopathy (MG) is an asymptomatic pre-cancerous clonal proliferation of
plasma cells. The onset of this disease is concealed, usually discovered by chance by
patients who undergo protein electrophoresis to detect monoclonal gamma globulin (M
protein) due to various clinical symptoms and disease evaluations. Due to the insidious
onset of monoclonal immunoglobulin, involving multiple organs, and the non-specific
clinical symptoms, it is more prone to misdiagnosis. This study hypothesized that among
patients who first came to the hospital for treatment, some patients had elevated serum
monoclonal immunoglobulin levels but were not initially diagnosed with hematology
department, but instead sought medical attention from other departments due to other
symptoms. In this study，by using a highly sensitive serum M protein detection method
based on the MALDI-TOF MS platform, serum monoclonal immunoglobul (M protein) in
detection was performed on the visiting patients to explore the positive rate of serum M
protein and its distribution in different departments，and to explore the correlation
analysis between the relative concentration of serum M protein based on the above highly
sensitive methods and clinical indicators.
Criteria for eligibility:
Study pop:
Patients over 18 years old attending the outpatient/emergency/inpatient departments of
Zhujiang Hospital, including departments such as hematology, general surgery,
dermatology, and others.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients attending the outpatient/emergency/inpatient department of Zhujiang
Hospital;
- Age: over 18 years old;
- There are sufficient remaining serum samples and extensive informed consent has been
signed.
Exclusion Criteria:
- Early diagnosis of hematological diseases such as plasma cell or other B lymphocyte
proliferative diseases；
- Improper storage or repeated freeze-thaw of remaining serum samples.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510280
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongwei Zhou, Professor
Phone:
18688489622
Phone ext:
+86
Email:
hzhou@smu.edu.cn
Start date:
October 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Zhujiang Hospital
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/NCT06082284
