Early Lymph Node Metastasis in T1/2 Stage Colorectal Cancer: Molecular and Clinical Insights
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,451
- 主要终点
- MSI status
研究概览
简要总结
The prognostic implications of lymph node metastasis in colorectal cancer patients at an early stage, specifically T1/2 stage, are relatively unfavorable. Therefore, understanding the clinical and molecular traits relevant to metastasis in T1/2 stage are of substantial clinical importance.
详细描述
Patients were classified based on their lymph node staging, with an ancillary categorization into MSI-H and MSS subgroups. A comparative mutational study was performed among these groups, incorporating risk stratification and Receiver Operating Characteristic curve analysis, with the aim of discerning the predictability of clinical features integrated with molecular characteristics for early metastasis in T1/2 stage colorectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-75 years old;
- •Clinical staged T2;
- •Histologically proven colon or rectal adenocarcinoma.
排除标准
- •Patients over 80 years of age;
- •Recurrent colorectal cancer;
- •Multiple primary tumors;
- •Distant metastasis.
结局指标
主要结局
MSI status
时间窗: through study completion, an average of 1 year
(I) MSI-High (MSI-H) if two or more mononucleotide markers in tumor tissue had size variations of ≥3bp compared to normal tissue; (II) MSI-Low (MSI-L) if a single mononucleotide marker in tumor tissue exhibited a size variation of ≥3bp compared to normal tissue; (III) Microsatellite Stable (MSS) if there were no size variations of ≥3bp in mononucleotide markers in tumor tissue compared to normal tissue.
次要结局
- Somatic Mutation Distribution(through study completion, an average of 1 year)
- Tumor Mutation Burden (TMB)(through study completion, an average of 1 year)