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Recruiting NCT05965115

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

— Observational Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sample of Blood.
Who it may be relevant to
Registry conditions: Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives [Time frame: 2 Years]
  • Time to progression (TTP) from MGUS to overt multiple myeloma [Time frame: 10 Years]
Secondary outcome measures (2)
  • Overall survival of MGUS patients [Time frame: 10 Years]
  • Quality of life (QoL) of MGUS patients [Time frame: 10 Years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan Hospital，Fudan University — Shanghai

Publications

  • 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. PMID 31598151

Identifiers

NCT: NCT05965115 · CHAPERONE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗