The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The mutation rate of the ctDNA of pediatric lymphoma
研究概览
简要总结
The next-generation sequencing (NGS) based on liquid biopsy has been an emerging technology to identify tumor-specific genetic aberrations in malignant tumors. The tumor tissue (FFPE) and plasma samples from the newly diagnosed pediatric lymphoma patients were collected and sequenced by 475 genes panel before, during and post treatment, to evaluate the significance of the ctDNA in efficacy prediction, predicting recurrence or mechanism of resistance to chemotherapy for pediatric lymphoma.
详细描述
This is a prospective, multi-center, observational cohort study. The tumor tissue (FFPE) and plasma samples (bone marrow or cerebrospinal fluid samples if necessary) from the newly diagnosed patients were collected and sequenced by 475 genes panel before, during and post treatment. Collection and analysis the results of ctDNA and chemotherapy response, to explore the mutation map of pediatric lymphoma and to evaluate the significance of liquid biopsy for efficacy prediction, predicting recurrence, mechanism of resistance to chemotherapy.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with pediatric lymphoma (HL and NHL) that met the criteria and required treatment upon histological and pathological diagnosis;
- •Age: < 18 years old;
- •The working status of the Eastern Cooperative Oncology Group (ECOG) (PS) : 0-2 points;
- •CT/MRI measurable lesion was defined as the longest diameter of at least 1 lymph node ≥ 1.5cm, and it was clearly measurable in 2 vertical directions;
- •Complete clinical laboratory examination and pathological examination information;
- •Patients can be evaluated on time, and the required samples can be obtained throughout the testing process;
- •After the patient is informed of the project, the informed consent signed by the patient or his legal representative is obtained.
排除标准
- •Patients with any of the following items will not be enrolled in this study:
- •Incomplete baseline samples (preoperative plasma samples, tissue, bone marrow, cerebrospinal fluid) due to various reasons;
- •The follow-up samples cannot be obtained during the monitoring process;
- •The researcher considered it unsuitable for enrollment.
结局指标
主要结局
The mutation rate of the ctDNA of pediatric lymphoma
时间窗: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient
次要结局
未报告次要终点
研究者
Yizhuo Zhang
Director of department of pediatric cancer,Principal Investigator,Clinical Professor
Sun Yat-sen University