Longitudinal Data Registry of A Spectrum of Plasma Cell Dyscrasia With Long-term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The goal of this multicenter observational study is to better understand the clinical and molecular characteristics, disease progression, treatment response, and clinical outcomes of patients with plasma cell dyscrasias, including monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, and light-chain amyloidosis. The study is led by Zhongshan Hospital, Fudan University, in collaboration with 18 other research centers in China. The main questions it aims to answer are:
Which clinical, laboratory, pathological, immunologic, cytogenetic, and genomic characteristics are associated with disease progression, treatment response, and patient outcomes? How do plasma cell dyscrasias and their underlying clones evolve over time? Can clinical and molecular information be used to develop models that predict disease progression and patient outcomes?
Researchers will collect and analyze historical and prospective clinical data from participating centers and follow patients over time. Participants' clinical course, laboratory and other test results, treatments, disease progression, and outcomes will be recorded and analyzed. This is an observational study and does not assign participants to any specific treatment.
详细描述
PCD is a spectrum of diseases that is being gradually understood in Asia. This study aims to observe and describe the clinical and genetic characteristics of Chinese PCD patients, and to explore the relationship between the characteristics and pathogenesis. It also aims to discover the potential distinct clonal evolution patterns among different subtypes of this disease spectrum. This study is a non-interventional, real-world, multicenter study. All registered data are collected from real-world clinical practice. The medical data include patient demographics, tumor characteristics, laboratory examinations, treatment history, adverse reactions, efficacy results, and potential prognostic factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathological diagnosis of PCD [e.g., symptomatic/asymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis] from 2007 to 2027 in Zhongshan Hospital or other collaborating centers.
- •Patients who had complete diagnostic, treatment, and follow-up records.
- •Patients with full comprehension and signature of the informed consent form (ICF) for participation.
排除标准
- •Patients who refused to use reliable methods of contraception during pregnancy, lactation, or the age-appropriate period.
- •Patients who suffered from severe mental illness.
- •Patients who were deemed unsuitable for inclusion by the investigator.
结局指标
主要结局
Overall survival
时间窗: From the time of enrollment to data cut-off (Up to approximately 20 years).
Overall survival (OS) refers to the time from receiving the first dose of regimen to death of any cause.
次要结局
- Progression-free survival(From the time of enrollment to data cut-off (Up to approximately 20 years).)
研究者
Peng Liu
Zhongshan Hospital, Fudan University
Shanghai Zhongshan Hospital