Prospective Clinical Trial for the Evaluation of Radiogenomics: Correlation, Treatment Response and Prognosis in Patients With Advanced Rectal Cancer, Who Undergo Preoperative Chemoradiation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- K-RAS Mutation
研究概览
简要总结
In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared.
Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival.
A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-80 years
- •Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery
排除标准
- •Patients with distal metastases confirmed at diagnosis
- •Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer
- •If patients do not agree with this study
结局指标
主要结局
K-RAS Mutation
时间窗: 4 weeks
K-RAS Mutation status
次要结局
- Radiomics - MR image findings(4 weeks)
研究者
Dae Kyung Sohn
Principal Investigator
National Cancer Center, Korea