Screening for M-protein in relatives of multiple myeloma patients in China
The China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) --A Multicenter Observational Study
This study is trying to see if screening for a specific protein in the blood can help find early signs of a blood condition in family members of people with multiple myeloma in China.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05965115 on ClinicalTrials.gov |
What this trial studies
The CHAPERONE study aims to evaluate the clinical significance of screening for monoclonal gammopathy (M-protein) in first-degree relatives of patients with multiple myeloma in China. It will establish a prospective cohort of individuals with monoclonal gammopathy of undetermined significance (MGUS) and study the prevalence, progression, and influencing factors of this condition. Participants will undergo M-protein screening through serum electrophoresis, and those with detected M-protein will receive further diagnostic assessments and follow-up care.
Who should consider this trial
Good fit: Ideal candidates are first-degree relatives of multiple myeloma patients who are over 18 years old.
Not a fit: Patients with a known diagnosis of plasma cell diseases, such as MGUS or multiple myeloma, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and monitoring of individuals at risk for developing multiple myeloma.
How similar studies have performed: Other studies have shown success in screening for monoclonal gammopathy, indicating that this approach has potential benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female over the age of 18; 2. First-degree relatives (including parents, children, and biological siblings) have multiple myeloma diagnosed by the International Myeloma Working Group (IMWG) Myeloma Diagnostic Criteria; 3. Understand the purpose and procedure of this trial and voluntarily participate in this screening study; 4. Participants should be willing and able to follow the study follow-up plan and other protocol requirements. Exclusion Criteria: Patients with a known diagnosis of plasma cell diseases, such as MGUS, smoldering myeloma (SMM), or multiple myeloma
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital，Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Peng Liu, PhD, MD — Fudan University
- Study coordinator: Peng Liu, PhD, MD
- Email: liu.peng@zs-hospital.sh.cn
- Phone: +8621-64041990
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.