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

The goal of the China Monoclonal Gammopathy Screening Project in First-degree Relativesof Patients With Multiple Myeloma (CHAPERONE) study is to assess the clinicalsignificance of screening for monoclonal gammopathy (M-protein) in first-degree relativesof patients with multiple myeloma in China population, and establish a prospective cohortof individuals with monoclonal gammopathy of undetermined significance (MGUS), aprecursor conditions to multiple myeloma. We will study these patients as a means toidentify 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.

Recruiting
Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance

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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Zhongshan Hospital,Fudan University
Shanghai, Shanghai, China

Investigator: Peng Liu, Ph.D
Contact: +862164041990
liu.peng@zs-hospital.sh.cn

Contacts

Peng Liu, PhD, MD
+8621-64041990 - 2925
liu.peng@zs-hospital.sh.cn

Jing Li, MD
+8621-64041990 - 2025
li.jing6@zs-hospital.sh.cn

Peng Liu, PhD, MD, Principal Investigator
Fudan University

Shanghai Zhongshan Hospital
NCT Number
Keywords
Monoclonal Gammopathy of Undetermined Significance
Multiple myeloma
Early Tumor Screening
MeSH Terms
Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance