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

NCT06082284 | Recruiting

• 1 other identifier: Zhujiangzny
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; M Protein

Keywords

M protein

Outcome Measures

Primary Outcomes (2)

• Positive rate of M protein

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

  one year

• The distribution of positive rate of M protein in different departments

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

  one year

Secondary Outcomes (1)

• Correlation analysis

  one year

Study Arms (1)

Patients who come to the hospital for treatment

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hongwei Zhou, Professor

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Nianyi Zeng

CONTACT

13928801657; zengny1@i.smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: October 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)