A Cross-sectional Study on the Positive Rate of M Protein Based on a Highly Sensitive Serum M Protein Detection Method.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06082284
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zhujiang Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hongwei Zhou, Professor
Principal Investigator Affiliation	Zhujiang Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma, M Protein

Additional Details

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.

Arms & Interventions

Arms

: Patients who come to the hospital for treatment

Patients attending the outpatient/emergency/inpatient department of Zhujiang Hospital over 18 years old.

Interventions

Contact a Trial Team

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International Sites

Guangzhou, Guangdong, China

Status

Recruiting

Address

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280

Site Contact

Hongwei Zhou, Professor

hzhou@smu.edu.cn

18688489622 #+86

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