Assessment of the Minimal Residual Disease in Diffuse Large B-Cell Lymphomas (DLBCL) From Cell-free Circulating DNA by Next Generation Sequencing (NGS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Determine the clonal evolution during and after treatment by Next Generation Sequencing
研究概览
简要总结
This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment
详细描述
To determinate and to describe the clonal evolution, 30 DLBCL cases with available matched tumor DNA and plasma will be collected and analyzed by routinely applicable next generation sequencing (NGS) at the time of diagnosis, at mid treatment, at the end of treatment and at 12 months after diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age up to 18 years old
- •With a diagnosis formally established of DLBCL or transformed straightaway follicular lymphoma or 3B grade follicular lymphoma or Burkitt-like lymphoma
- •Eligible to a treatment by immunochemotherapy like R-CHOP, R-ACVBP or R-CHOP like
- •First line of treatment
- •Being able to benefit from standard extension assessment ( Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) and bone marrow biopsy with a bone marrow aspiration)
- •Written informed consent
- •Tumor biopsy used for diagnosis available
排除标准
- •Patient who cannot receive polychemotherapy like R-CHOP, R-ACVBP, or R-CHOP like
- •Patient who cannot benefit from standard extension assessment and follow-up by with Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)
- •Pregnant or breast-feeding woman
- •Guardianship, curatorship
- •Patient who cannot follow the medical procedures of the study for geographic, social, psychological,linguistic or physical reasons
结局指标
主要结局
Determine the clonal evolution during and after treatment by Next Generation Sequencing
时间窗: one year
DNA from tumor, DNA from peripheral blood and DNA from bone marrow will be sequencing by NGS for a panel of 34 genes.
次要结局
- Progression free survival(One year)
- Overall survival(one year)
- Assess the clonal architecture in tumor DNA and bone marrow(one year)
- Compare the Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) procedure and the kinetic and pattern of somatic mutations identified in cfDNA(one year)