NCT06813573招募中不适用
Prospective Analysis of Circulating Nucleosomes in Patients Receiving a First Line Treatment for a Non-Hodgkin Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prospective quantitative analysis of the level of circulating nucleosomes at baseline and during treatment in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL)
研究概览
简要总结
The goal of this study is to prospectively follow the level of circulating nucleosomes in patients treated for a non-Hodgkin lymphoma and determine whether it correlates with the clinical response.
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
- •Histologically proven diagnosis of diffuse large B cell lymphoma or follicular lymphoma, according to the WHO 2016 classification, requiring a first line of treatment with a RCHOP 21 regimen
- •Agreement to participate after receiving oral and written information on the study
排除标准
- •History of previous treatment for lymphoma (excluding localized low dose radiotherapy in the case of follicular lymphoma)
- •Treatment with a chemotherapy regimen different from RCHOP21
研究组 & 干预措施
Patients receiving first line of treatment with a RCHOP 21 regimen
Experimental
All patients will receive first line of treatment with a RCHOP 21 regimen
干预措施: blood sampling (Biological)
结局指标
主要结局
Prospective quantitative analysis of the level of circulating nucleosomes at baseline and during treatment in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL)
时间窗: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)
次要结局
- Correlation between the level of circulating nucleosomes (number of cells) and the response to treatment as defined by international response criteria(From enrollment to the end of the treatment (6 cycles of 21 days))
- Comparison between the results of molecular analysis of ctDNA and DNA extracted from nucleosomes(From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient))
研究者
研究点 (1)
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