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

NCT ID: NCT06082284

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma M Protein

Keywords

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M protein

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients who come to the hospital for treatment

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongwei Zhou, Professor

Role: STUDY_CHAIR

Zhujiang Hospital

Locations

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Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nianyi Zeng

Role: CONTACT

Phone: 13928801657

Email: [email protected]

Facility Contacts

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Hongwei Zhou, Professor

Role: primary

Other Identifiers

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Zhujiangzny

Identifier Type: -

Identifier Source: org_study_id