Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Quantitative analysis of ctDNA level during the first-line chemotherapy
研究概览
简要总结
Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age <60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy.
详细描述
Samples of plasma from peripheral blood will be taken for investigational ctDNA examination during the specific timepoints: at diagnosis, after 2 cycles of initial chemotherapy, at the end of chemotherapy, 3 months after radiotherapy, at the diagnosis of the first relapse, after salvage chemotherapy before ASCT, 3 months after ASCT, at the diagnosis of second relapse and every 3 months during brentuximab vedotin treatment or during nivolumab treatment until progression. The buccal swab for germline DNA extraction will be performed at the time of enrollment into the study. Samples of peripheral blood for EBV-DNA analysis will be obtained from the EBV-positive cHL patients to measure EBV load at the same time-points as ctDNA. Microdissected HRS cells from fresh frozen biopsies at the diagnosis and at the relapse will be used for tumor cells next generation sequencing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma (cHL) will be enrolled
- •signing the informed consent
排除标准
- •Pacients without signing the informed consent
结局指标
主要结局
Quantitative analysis of ctDNA level during the first-line chemotherapy
时间窗: 4 years
Quantitative analysis of ctDNA level during the first-line chemotherapy: 1. analysis in relation to the type of chemotherapy: BEACOPP escalated vs ABVD 2. dynamics of ctDNA decline in correlation with treatment response
Identification of tumor specific mutation profiles at relapse of classical HL
时间窗: 4 years
Identification of tumor specific mutation profiles at relapse of classical Hodgkin lymphoma: 1. detection of newly developed mutations in comparison to the initial diagnosis 2. characteristics of mutations in HL tumors refractory to brentuximab vedotin 3. characteristics of mutations in HL tumors refractory to nivolumab
Identification of tumor specific mutation profiles at dg. of HL based on ctDNA
时间窗: 4 years
Identification of tumor specific mutation profiles at diagnosis of classical Hodgkin: 1. age at diagnosis \< 60 years in comparison to patients with age at diagnosis 60 years and more 2. EBV negative versus EBV positive cases 3. correlation with the first line treatment outcome lymphoma based on ctDNA analysis with correlation to clinical and pathological characteristics
次要结局
- In vitro functional characterization of identified DNA variants and/or mutations(4 years)