The Significance of Dynamic Monitoring of ctDNA in Pediatric Soft Tissue Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The rate to detected tumor progression by ctDNA before radiographic tumor progression
研究概览
简要总结
Pediatric soft tissue sarcoma is made up of different subtypes, some of which have distinct genetic alterations. Fusion variants were found in about 43% of bone and soft tissue sarcoma samples. Ewing sarcoma is characterized by recurrent chromosome translocation, with up to 95% of cases showing EWS-ETS translocation. The genetic features of the tumor can change as it spreads or shrinks, and can also be influenced by treatment.
To better understand treatment response and predict relapse early, our study collects liquid samples such as blood, bone marrow, or cerebrospinal fluid at various points during treatment. We then use next-generation sequencing to dynamically monitor the unique genetic profile of the tumor. Additionally, our research may identify new genetic targets and suggest potential treatment options.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) pediatric patients with soft tissue sarcoma confirmed by pathology(including but not limited to rhabdomyosarcoma, Ewing sarcoma, BCOR rearrangement undifferentiated sarcoma, CIC rearrangement undifferentiated sarcoma, Epithelioid sarcoma and synovial sarcoma.
- •(2)younger than 18 years old.
- •(3)ECOG status: PS score0-
- •(4)measurable lesions on CT/MRI according to RECIST 1.1 criteria : long diameter≥10mm; the longest diameter on ≥ one lymphnode ≥1.5 cm.
- •(5)sufficient clinical and pathological information.
- •(6)candidates can receive evaluation on time and provide samples during the trials.
- •(7)candidates should be informed and provide informed consents.
排除标准
- •Sufficient samples at baseline point can not be obtained including pre-operation plasma, tissues, bone marrow aspirate and cerebrospinal fluid.
- •Plasma samples can not be obtained during monitoring.
- •Ineligible candidates at the discretion of researchers.
结局指标
主要结局
The rate to detected tumor progression by ctDNA before radiographic tumor progression
时间窗: Oct,2022-Dec 2023,recruting patients; Jan 2024-Mar 2024,analyzing the genetic features in samples;Jan 2023-May 2024,follow up patients
1. Progression-Free Survival PFS is defined as the time from randomization to progression or death. 2. The definition of ctDNA positive samples : at least one of somatic alterations detected by 475-gene panel.
次要结局
未报告次要终点
研究者
Yizhuo Zhang
Director of Pediatric Oncology
Sun Yat-sen University