Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- TTP
研究概览
简要总结
Despite the common application of radiotherapy in cancer treatment, the prediction of radiosensitivity and treatment response has not yet entered the era of precision medicine. Therefore, development of genome-based methods for predicting radiosensitivity and treatment response is a central goal of radiation oncology. In the previous study, the investigators have identified a set of novel potential biomarkers associated with radiosensitivity and recurrence，through correlating patients' genomic profiles with toxicity, disease progression and overall survival after RT.
详细描述
Researchers have long recognized that individual differences in sensitivity to radiation are caused by genetic variations and implicated multiple key pathways that might explain radiation toxicity. Normal tissue toxicity is a complex trait that involves the combined effect of a multitude of genes and pathways, and also dynamic interactions with the evolving cancer genome. The effect size of any individual factor is likely small. As a consequence, candidate gene approach and genome-wide association studies rarely lead to the identification of genetic determinants of radiation toxicity. Targeted next-generation sequencing (NGS), on the other hand, has become increasingly routine in the clinic and would allow simultaneous assessment of multiple genetic alterations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with locally advanced solid tumors (lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma cancer and liver cancer) identified by cytology and pathology;
- •Patients need conventional fractionation and adequate radiotherapy;
- •Age ≥ 18 years old, male and female;
- •Expected survival time ≥ 12 weeks;
- •PS score 0-2 within 2 weeks before admission to the group;
- •There are tumor tissue samples and blood samples can be used for NGS inspection;
- •Patients volunteered to join this study, sign informed consent, provide all diagnosis and treatment data after cancer diagnosis before entering the group, good compliance, cooperate with follow-up.
排除标准
- •The patient's previous radiation therapy leads to overlapping potential fields;
- •Stage IV patients and stage I patients to be treated with SBRT
- •The patient cannot receive regular imaging examinations;
- •Any serious or uncontrolled signs of systemic disease that the investigator believes may significantly affect the patient's risk/benefit balance, including hepatitis B, hepatitis C, and human immunodeficiency virus;
- •The researcher believes that it is not suitable for the group.
结局指标
主要结局
TTP
时间窗: 2 years
Time to progression
OS
时间窗: 2 years
Time to death
次要结局
未报告次要终点
研究者
Jinming Yu
President
Shandong Cancer Hospital and Institute