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Trial Title:
The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study
NCT ID:
NCT05965115
Condition:
Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Conditions: Keywords:
Monoclonal Gammopathy of Undetermined Significance
Multiple Myeloma
Early Tumor Screening
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Sample of Blood
Description:
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.
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.
Criteria for eligibility:
Study pop:
The first-degree relatives of patients with multiple myeloma in the Chinese population.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital，Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Liu, Ph.D
Phone:
+862164041990
Phone ext:
2925
Email:
liu.peng@zs-hospital.sh.cn
Contact backup:
Last name:
Jing Li, M.D.
Phone:
+862164041990
Phone ext:
2025
Email:
li.jing6@zs-hospital.sh.cn
Investigator:
Last name:
Peng Liu, Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Jing Li, M.D.
Email:
Sub-Investigator
Start date:
July 2023
Completion date:
August 2035
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965115
