ESCC Molecular Subtypes Based on Multidimensional Features of p53 and Their Clinical Significance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time from surgery to death from any cause (for Overall Survival) or to disease recurrence/local-regional failure (for Recurrence-Free Survival).
研究概览
简要总结
Collect 300 esophageal cancer tissue specimens, including cancer tissue and serum, from a biological sample bank. Collect clinical information on esophageal cancer, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc. DNA sequencing was performed on 300 collected esophageal cancer samples, divided into mutant and wild-type types. Perform immunohistochemistry on tissue slices and observe the expression of P53 mutant protein. ELISA was used to study the expression of serum anti-P53 autoantibodies. Process these data and use them to classify subtypes of esophageal cancer. Associate each subtype with clinical information, analyze the characteristics of each subtype, such as the multidimensional features of P53 and treatment correlation analysis, and the correlation between P53 multidimensional features and survival.
详细描述
Specific research design
- Collect information on all clinical cases of esophageal cancer in the study, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc.
- Perform DNA sequencing on the collected esophageal cancer tissue samples, identify gene mutation sites, and group them according to different types of mutations.
- Perform ELISA on the collected serum of esophageal cancer patients to distinguish between groups with negative and positive autoantibodies.
- Perform immunohistochemistry on tumor tissue slices collected from esophageal cancer patients, observe the expression of mutant P53 protein, and obtain samples with positive immunohistochemistry for P53 protein.
- Based on the presence or absence of P53 mutations, the expression of mutant P53 protein in immunohistochemistry, and the positive or negative autoantibodies in serum, further subtype classification criteria will be developed.
- Associate different subtypes of esophageal cancer with clinical and pathological features, identify their respective characteristics, and provide guidance for clinical diagnosis, treatment, and prognosis. Univariate and multivariate survival analysis of clinical pathological parameters and the correlation between this subtype and DFS and OS in cancer patients; Kaplan Meier curve analysis of the relationship between this subtype and patient survival, as well as its expression for cancer risk assessment.
Specific research design
- Collect information on all clinical cases of esophageal cancer in the study, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc.
- Perform DNA sequencing on the collected esophageal cancer tissue samples, identify gene mutation sites, and group them according to different types of mutations.
- Perform ELISA on the collected serum of esophageal cancer patients to distinguish between groups with negative and positive autoantibodies.
- Perform immunohistochemistry on tumor tissue slices collected from esophageal cancer patients, observe the expression of mutant P53 protein, and obtain samples with positive immunohistochemistry for P53 protein.
- Based on the presence or absence of P53 mutations, the expression of mutant P53 protein in immunohistochemistry, and the positive or negative autoantibodies in serum, further subtype classification criteria will be developed.
- Associate different subtypes of esophageal cancer with clinical and pathological features, identify their respective characteristics, and provide guidance for clinical diagnosis, treatment, and prognosis.
Univariate and multivariate survival analysis of clinical pathological parameters and the correlation between this subtype and DFS and OS in cancer patients;
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed esophageal squamous cell carcinoma (ESCC); Age ≥ 18 years; Undergone surgical resection; Availability of p53 molecular data and clinical follow-up data.
排除标准
- •Incomplete medical records or missing key clinicopathological data. Non-squamous histological types.
结局指标
主要结局
Time from surgery to death from any cause (for Overall Survival) or to disease recurrence/local-regional failure (for Recurrence-Free Survival).
时间窗: Data collected up to December 31, 2024
次要结局
未报告次要终点
研究者
Ling Zhiqiang
Prof., M.D., PhD,
Zhejiang Cancer Hospital
