NCT06750965Not yet recruiting
Multi-center Screening for Serum M Protein
Epidemiological Characteristics Associated With Precursor Lesions of Multiple Myeloma Using Serum M Protein Screening: a Multi-center, Prospective Cohort Study.
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to utilize a highly sensitive method for detecting M protein in serum to examine the prevalence of M protein in various age groups of individuals aged over 30 who underwent physical examinations in different regions of China. Furthermore, the study seeks to analyze the relationship between physical examination indicators and the presence of serum M protein (as measured by relative intensity) in the study participants at the time of enrollment. Additionally, a 5-year follow-up period will be employed to observe the association between annual physical examination indicators and clinical outcomes in subjects identified with positive/negative serum M protein screening.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 4 Jan 2024
- Start date
- 1 May 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Zhujiang Hospital
- Diseases
- Multiple myeloma
- NCT number
- NCT06750965
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 1 May 2025 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 1\) Previously diagnosed with hematological diseases such as plasma cell or other B lymphocyte proliferative diseases.
- Unqualified samples: including serum samples with severe hemolysis, fatty blood or jaundice, insufficient sample, and samples not stored as required.
Other
- (1) Screening stage
- Culling criteria:
- Samples with incomplete or untraceable subject data.
- The subject requested to withdraw from the study midway.
- Duplicate samples of subjects at the same time point.
Who the study is looking for
- (1) Screening stage
- Over 30 years old.
- Volunteer to participate in this study and sign an informed consent form.
- (2) Follow up stage
- According to previous studies, a positive rate of 5% -8% was found in subjects with positive M protein screening. Each sub center included approximately 50-80 positive subjects based on actual conditions. At the same time, control subjects with negative M protein testing were matched by age and gender parameter 1:1.
- Volunteer to participate in the follow-up phase of the study and sign an informed consent form.
Age in the registry: 30 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.