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临床试验/NCT06330896
NCT06330896尚未招募不适用

Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing

Siriraj Hospital0 个研究点目标入组 498 人开始时间: 2024年4月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chutima Kunacheewa

lecturer

Siriraj Hospital

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