Exploring M Protein Levels in Patients Using a Sensitive Detection Method
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.
This study is testing a new method to see if it can help find high levels of a specific protein in the blood of patients who might have a condition called monoclonal gammopathy, which often goes undiagnosed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06082284 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the positive rate of serum monoclonal immunoglobulin (M protein) in patients visiting various departments at Zhujiang Hospital. Utilizing a highly sensitive detection method based on the MALDI-TOF MS platform, the study will analyze serum samples to determine the prevalence of elevated M protein levels and their correlation with clinical indicators. The research focuses on patients who may have undiagnosed monoclonal gammopathy, often misidentified due to non-specific symptoms. By identifying these cases, the study seeks to improve early detection and diagnosis of related conditions.
Who should consider this trial
Good fit: Ideal candidates include patients over 18 years old attending outpatient, emergency, or inpatient departments at Zhujiang Hospital with sufficient serum samples.
Not a fit: Patients with early diagnoses of hematological diseases or those with improperly stored serum samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early diagnosis and treatment of multiple myeloma and related conditions, potentially improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving detection rates of monoclonal gammopathy using advanced methodologies.
Eligibility criteria
Show full 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.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Nianyi Zeng
- Email: zengny1@i.smu.edu.cn
- Phone: 13928801657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.