NCT06286215尚未招募不适用
Registry of Patients With Plasma Cell Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 750
- 主要终点
- register the plasma cell disorder patients
研究概览
简要总结
The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:
- The incidence of plasma cell disorders both before and after malignancy
- Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
- Progression free survival (PFS)
- overall survival
- factors influencing overall survival, progression-free survival, and time to progression
- Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.
- genetic characteristics of plasma cell disorder
- cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both existing and newly diagnosed patients with plasma cell disorders, including monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS, light chain amyloidosis, solitary plasmacytoma, and multiple myeloma, according to the diagnostic criteria of the International Myeloma Working Group 2014
- •Aged 18 years and above
排除标准
- •insufficient data needed for analysis
结局指标
主要结局
register the plasma cell disorder patients
时间窗: 10 years
register the plasma cell disorder patients
次要结局
- overall survival(10 years)
- influencing factors(10 years)
- Progression free survival(10 years)
- incidence of plasma cell disorders(10 years)
- cost-effectiveness(10 years)
- Time to progression(10 years)
- Symptoms and signs(10 years)
- genetic characteristics(10 years)
研究者
Chutima Kunacheewa
lecturer
Siriraj Hospital
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