Exploration of Potential Biomarkers to Predict Tumor Response to Radiotherapy in Patients With Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Tumor short-term response to therapeutics
研究概览
简要总结
This study aims to explore potential biomarkers for prediction of therapeutic outcomes in patients with solid tumors after radiotherapy
详细描述
Patients pathologically confirmed with solid tumors that requires radiotherapy or surgery will be recruited to this study. Tumor samples were obtained from patients underwent surgery to establish the baseline status of biomarker assessed. Peripheral and microbiota will also be collected before and after surgery. For patients undergoing radiotherapy, tumor biopsy as well as collection of blood samples and microbiota will be performed during the course of treatment. These biological specimens will be used for assessment of tumor phenotypes and for exploration of potential biomarkers that could predict the tumor response to therapeutics and prognsis in patients with solid tumors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological proven diagnosis of solid tumors
- •Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery
- •Patient must provide study-specific informed consent prior to study entry
排除标准
- •History of autoimmune diseases
- •History of immunotherapy
- •Prior radiation therapy that would result in overlap of planned radiation therapy fields
- •Will receive immunotherapy during the course of radiotherapy
- •Contraindications for biopsy, such as high bleeding risk
结局指标
主要结局
Tumor short-term response to therapeutics
时间窗: Within 1 month after the completion of radiotherapy
For patients treated with radiotherapy, shortly after the completion of treatment, the short-term response was assessed by using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) .
Tumor long-term response to therapeutics
时间窗: up to 3 years of follow-up
For patients treated with radiotherapy, tumor response was assessed by using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) .
Expression status of biomarkers and their dynamic changes during treatment and follow-up
时间窗: From the date of enrollment until the date of disease progression, assessed up to 3 years
Expression status of biomarkers and their dynamic changes in patients' biological specimens through the course of treatment and during follow-up as assessed by a variety of means, including RNA-seq, DNA-seq, RT-qPCR, IHC, WB and ELISA.
次要结局
- Disease-specific survival(up to 3 years of follow-up)
研究者
Chuangzhen Chen
Deputy Director, Department of Radiation Oncology
Shantou University Medical College