Genomic Study of Relapse Esophageal Cancer After Radiotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- genomic characteristics of relapsed esophageal cancer
研究概览
简要总结
Radiotherapy plays an important role in multidisciplinary treatment of esophageal cancer. However, about half patients received radiotherapy occurred relapse. Once relapse occurred, there is no better treatment strategy. Genomic study of relapsed esophageal cancer is seldom. So the investigators attempt to collect relapsed tissue to conduct with whole exome sequencing in order to investigate the genome landscape of recurrence esophageal cancer.
详细描述
Tumor tissue of patients received radiotherapy with diagnosis of recurrence between Jan 1, 2010 and Dec 1, 2020 were collected retrospectively. Recurrence tumor tissue is collected between Dec 31, 2020 and Dec 31, 2022 prospectively. Blood and preradiotherapy tumor tissue were also collected to be as contrast. A total of 100 paired blood, preradiotherapy tumor tissue and relapse tumor tissue were collected. What is more, a total of 100 paired blood and preradiotherapy tumor tissue with diagnosis of no recurrence were collected. All samples were conducted with whole exome sequencing.
Here the investigators define recurrence period as within 2 years and no recurrence period as more than 3 years after radiotherapy.
Criteria of relapse: (1) pathologic diagnosis is squamous carcinoma before radiotherapy;(2) received radiotherapy; (3)pathologic diagnosis is also squamous carcinoma after radiotherapy; (4) clinical symptoms including feeding obstruction etc; (5) imaging evidence showed disease progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologic diagnosis is squamous cell carcinoma before radiotherapy;
- •pathologic diagnosis is squamous cell carcinoma after radiotherapy;
- •received radiotherapy
- •clinical symptoms including dysphagia, feeding obstruction, etc
- •image evidence showed disease progression
- •the period of recurrence was within 2 years after radiotherapy
排除标准
- •pathologic diagnosis is not squamous cell carcinoma before radiotherapy;
- •pathologic diagnosis is not squamous cell carcinoma after radiotherapy
- •not received radiotherapy
- •the period of recurrence was more than 2 years after radiotherapy
- •the period of no recurrence was within 3 years after radiotherapy
结局指标
主要结局
genomic characteristics of relapsed esophageal cancer
时间窗: through study completion, an average of 1 year
gene mutations, copy number variants
次要结局
未报告次要终点