Assessment of DNA Methylation Signatures in Lymphocytes for Evaluating the Efficacy and Prognosis of Immunotherapy in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
The goal of this observational study is to assess lymphocyte levels in colorectal cancer patients using DNA methylation levels in tissues or blood. The main questions it aims to answer are:
Can DNA methylation features calculate lymphocyte levels? Can the calculated lymphocyte levels assess the efficacy and prognosis of immunotherapy?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosed with colorectal cancer by colonoscopy pathology and deemed eligible for immunotherapy after assessment.
- •Neoadjuvant immunotherapy regimen includes PD-1 or anti-PD-L
- •R0 resection is performed after neoadjuvant immunotherapy.
- •Complete immunotherapy efficacy assessment data and follow-up data are available.
- •The tissue bank stores the required whole blood and tissue samples for the experiment.
排除标准
- •Concurrent other malignancies.
- •Neoadjuvant immunotherapy not conducted according to the standard protocol.
- •Severe adverse chemotherapy reactions that lead to the discontinuation of immunotherapy midway.
- •Lack of complete neoadjuvant chemotherapy efficacy assessment data or follow-up data.
- •The tissue bank does not store the required whole blood or tissue samples for the experiment.
- •Patients with concurrent other immune system diseases.
结局指标
主要结局
Complete Response Rate
时间窗: From the date of neoadjuvant therapy until the date when the surgical specimen pathology results are obtained, the duration of neoadjuvant therapy is approximately half a year, with a maximum of one year.
The complete response rate refers to the percentage of patients who experience a complete disappearance of their disease after treatment.
次要结局
未报告次要终点
研究者
Yanxin Luo,MD
Head of Gastroenterology
Sixth Affiliated Hospital, Sun Yat-sen University