Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 498
- 主要终点
- genetic landscape of PCD
研究概览
简要总结
The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are:
- genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing
- genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients.
- disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS.
- correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients.
The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis
- •Aged 18 years and older
- •Performed FISH and/or NGS testing
- •Has treatment follow up at least one year
排除标准
- •Patients with missing crucial data that renders them unanalyzable
- •Patients who refuse to participate in the study
结局指标
主要结局
genetic landscape of PCD
时间窗: 18 months in 498 patients
number and percentage of genetic landscape of FISH and NGS in patients with Plasma Cell Disorders
次要结局
- age(18 months in 498 patients)
- overall survival(18 months)
- progression free survival(18 months)
- gender(18 months in 498 patients)
- genetic correlation(18 months in MM patients)
- factor of genetic landscape differentiation(18 months in MM patients)
- genetic landscape of relapse MM patients(18 months in MM patients)
研究者
Chutima Kunacheewa
lecturer
Siriraj Hospital
