RecruitingNCT05965115

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


Sponsor

Shanghai Zhongshan Hospital

Enrollment

10,000 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Male or female over the age of 18;
  • First-degree relatives (including parents, children, and biological siblings) have multiple myeloma diagnosed by the International Myeloma Working Group (IMWG) Myeloma Diagnostic Criteria;
  • Understand the purpose and procedure of this trial and voluntarily participate in this screening study;
  • Participants should be willing and able to follow the study follow-up plan and other protocol requirements.

Exclusion Criteria1

  • Patients with a known diagnosis of plasma cell diseases, such as MGUS, smoldering myeloma (SMM), or multiple myeloma

Interventions

DIAGNOSTIC_TESTSample 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.


Locations(1)

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

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NCT05965115


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