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NCT Number: NCT06082284

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location status: Recruiting

Location contact

Hongwei Zhou, Professor

CONTACT

[email protected]

18688489622 ext. +86

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Positive rate of M protein

    Time frame: one year

    Positive rate of serum M protein in patients seeking medical treatment at the hospital

  2. The distribution of positive rate of M protein in different departments

    Time frame: one year

    The positive rate of serum M protein in the patients visiting the hospital and its distribution in different departments.

Secondary outcomes

  1. Correlation analysis

    Time frame: one year

    Correlation analysis between the relative concentration of serum M protein and clinical indicators.

Study contacts

Contact information is provided by the study sponsor or research team.

Nianyi Zeng

CONTACT

[email protected]

13928801657 ext. +86

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2023
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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