The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study
NCT ID: NCT05965115
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2023-07-31
2035-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Peng Liu
Head of Department of Hematology
Principal Investigators
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Peng Liu, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CHAPERONE
Identifier Type: -
Identifier Source: org_study_id
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