[RADIOSARC] Searching for Specific Gene Signature(s) of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Adults Patients With Resectable Soft Tissue Sarcomas of Limbs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To define a transcriptomic signature of histological response to radiotherapy in STS patients using the percentage of residual viable cells as a clinical meaningful endpoint
研究概览
简要总结
To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Our proposal is to conduct a cohort study aiming at identifying transcriptomic biomarkers predictive of sensitivity and/or resistance to RT in limbs STS patients
详细描述
Whether RT should be performed pre or post-operatively is still a debated question. To date, the radiation oncologist are missing signature of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Therefore, predicting the likelihood of response/resistance to RT is essential. The individual exploration with high-throughput approaches will participate in describing biological mechanisms involved in STS tumor cell pan-resistance, thus identifying potential molecular targets that could be inhibited to reverse intrinsic radioresistance. In this context, our proposal is to conduct a cohort study aiming at identifying transcriptomic signature predictive of sensitivity and/or resistance to RT in limbs STS patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Male and female ≥ 18 years at time of non-opposition to participate to the study
- •Patient with documented non-opposition to participate to the study.
- •Patient with histologically and cytologically confirmed diagnosis with STS (..)
- •Patient with availability of FFPE tumor block from initial diagnosis biopsy (mandatory) and surgery specimen (optional).
- •Patients with tumor FFPE samples prepared with the last 4 years
- •Patient with evaluable tumor sample meeting the following quality/quantity control criteria (..)
排除标准
- •Patients with metastatic soft tissue sarcoma at diagnosis
- •Patients with exclusive radiotherapy without surgical resection
- •Patients receiving neo adjuvant systemic treatment (chemotherapy, immunotherapy, targeted therapy)
结局指标
主要结局
To define a transcriptomic signature of histological response to radiotherapy in STS patients using the percentage of residual viable cells as a clinical meaningful endpoint
时间窗: 36 months
Gene expression signature using RNAseq correlated to the percentage of residual viable cells on surgery specimen to define histological response.
次要结局
- To identify biomarkers of sensitivity or resistance to radiotherapy in STS patients using additional clinical endpoints(36 months)