Clinical trial NCT05965115: The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study
Official title: The China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) --A Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Keywords: Monoclonal Gammopathy of Undetermined Significance
Multiple Myeloma
Early Tumor Screening
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The first-degree relatives of patients with multiple myeloma in the Chinese population.

Brief 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.

Eligibility 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

Primary outcomes:
measure: The prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives
timeFrame: 2 Years
measure: Time to progression (TTP) from MGUS to overt multiple myeloma
timeFrame: 10 Years
Secondary outcomes:
measure: Overall survival of MGUS patients
timeFrame: 10 Years
measure: Quality of life (QoL) of MGUS patients
timeFrame: 10 Years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital，Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Peng Liu, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Wang Y, Liu P. The impact on early diagnosis and survival outcome of M-protein screening-driven diagnostic approach to multiple myeloma in China: a cohort study. J Cancer. 2019 Aug 27;10(20):4807-4813. doi: 10.7150/jca.32103. eCollection 2019.