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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.
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample of Blood | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives | The prevalence of MGUS in MM first-degree relatives: defined as the proportion of MGUS cases among the total population ( MM first-degree relatives) receiving M-protein screening | 2 Years |
| Time to progression (TTP) from MGUS to overt multiple myeloma | The time interval between the first diagnosis of MGUS and the first recording of participants and the diagnosis of myeloma. For participants who did not record disease progression to myeloma, the last follow-up date was used as the cut-off date. | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of MGUS patients | The time interval between the first diagnosis of MGUS and the recording of death from any cause. For participants whose death is not recorded, the cut-off date is the most recent point at which it is known that the participant is still alive. | 10 Years |
| Quality of life (QoL) of MGUS patients |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a known diagnosis of plasma cell diseases, such as MGUS, smoldering myeloma (SMM), or multiple myeloma
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The first-degree relatives of patients with multiple myeloma in the Chinese population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Liu, PhD, MD | Contact | +8621-64041990 | 2925 | liu.peng@zs-hospital.sh.cn |
| Jing Li, MD | Contact | +8621-64041990 | 2025 | li.jing6@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Peng Liu, PhD, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital，Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31598151 | Result | 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. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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QoL evaluation was performed using the Patient Self-Rating Scale (EORTC QLQ - C30) during the case screening period and at each follow-up period. |
| 10 Years |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006942 | Hypergammaglobulinemia |