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临床试验/NCT02627261
NCT02627261已完成不适用

Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma

Hospices Civils de Lyon3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
3
主要终点
Quantification of residual disease

研究概览

简要总结

Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease

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

入选标准

  • ≥ 18 years
  • previously undiagnosed myeloma
  • eligible for high dose therapy and bone marrow transplantation
  • signed consent

排除标准

  • ongoing therapy for another neoplasia
  • Patients with other hematologic malignancies,
  • patients deprived of liberty for administrative or judicial reasons
  • previously treated for myeloma

结局指标

主要结局

Quantification of residual disease

时间窗: Residual disease is assessed up to 18 months after inclusion

study the sensitivity of the method of quantification of circulating tumor cells compared to 2 others methods of detection

次要结局

  • kinetic of variation of the circulating tumor cells(18 months)
  • kinetic of variation of the residual tumor cells detected by flow cytometry method(18 months)
  • kinetic of variation of the residual tumor cells detected by new generation sequencing method(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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Multiple Myeloma Minimal Residual Disease | 临床试验