NCT05965115

The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study

The China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) --A Multicenter Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) study is to assess the clinical significance of screening for monoclonal gammopathy (M-protein) in first-degree relatives of patients with multiple myeloma in China population, and establish a prospective cohort of individuals with monoclonal gammopathy of undetermined significance (MGUS), a precursor conditions to multiple myeloma. We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

Detailed description

The CHAPERONE study aims to assess the clinical significance of screening for monoclonal gammopathy in first-degree relatives of patients with multiple myeloma in China. The main objectives it aims to answer are: * Main research objectives: To study the prevalence of MGUS, the time of disease progression, and its influencing factors in first-degree relatives of multiple myeloma patients in China. * Secondary study objective: To explore the clinical/genomic/epigenetic features, survival, and quality of life of MGUS patients in first-degree relatives of multiple myeloma patients in China. All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests, and patients with MGUS will be carefully assessed and followed up.

Conditions

• Multiple Myeloma
• Monoclonal Gammopathy of Undetermined Significance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sample of Blood	All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests to determine their accurate diagnosis. Patients with monoclonal gammopathy of undetermined significance (MGUS) would be carefully assessed and followed up.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-08-01
• Completion: 2035-08-01
• First posted: 2023-07-28
• Last updated: 2023-08-01

Locations

1 site across 1 country: China