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.
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.
Study Type
OBSERVATIONAL
Enrollment
10,000
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.
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives
The prevalence of MGUS in MM first-degree relatives: defined as the proportion of MGUS cases among the total population ( MM first-degree relatives) receiving M-protein screening
Time frame: 2 Years
Time to progression (TTP) from MGUS to overt multiple myeloma
The time interval between the first diagnosis of MGUS and the first recording of participants and the diagnosis of myeloma. For participants who did not record disease progression to myeloma, the last follow-up date was used as the cut-off date.
Time frame: 10 Years
Overall survival of MGUS patients
The time interval between the first diagnosis of MGUS and the recording of death from any cause. For participants whose death is not recorded, the cut-off date is the most recent point at which it is known that the participant is still alive.
Time frame: 10 Years
Quality of life (QoL) of MGUS patients
QoL evaluation was performed using the Patient Self-Rating Scale (EORTC QLQ - C30) during the case screening period and at each follow-up period.
Time frame: 10 Years
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