Clinical trial NCT06082284: A Cross-sectional Study on the Positive Rate of M Protein Based on a Highly Sensitive Serum M Protein Detection Method.
Official title: A Cross-sectional Study on the Positive Rate of Monoclonal Immunoglobulin (M Protein) in the Serum of Patients Seeking Medical Treatment in Tertiary Hospitals Based on a Highly Sensitive Serum M Protein Detection Method.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
M Protein
Keywords: M protein
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old attending the outpatient/emergency/inpatient departments of Zhujiang Hospital, including departments such as hematology, general surgery, dermatology, and others.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Positive rate of M protein
timeFrame: one year
measure: The distribution of positive rate of M protein in different departments
timeFrame: one year
Secondary outcomes:
measure: Correlation analysis
timeFrame: one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Hongwei Zhou, Professor
role: STUDY_CHAIR
References: