Predicting Postoperative Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Recurrence-free Survival（RFS)
研究概览
简要总结
The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Epigenomic alterations such as DNA methylation have attracted attention as promising biomarkers. The investigators aim to predict early recurrence based on whole genome DNA methylation analysis of esophageal cancer.
详细描述
Prognosis for patients with esophageal squamous cell carcinoma (ESCC) remains poor. Surgery is one of the standard treatments for patients with ESCC who are considered to have a curative resection, however, approximately 40% of patients develop tumor recurrence within two years after surgery. The main cause of poor prognosis in ESCC patients undergoing surgery is postoperative tumor recurrence due to the presence of latent micro-metastases at the time of surgery. Even with today's advances in preoperative diagnostic techniques, predicting early tumor recurrence remains difficult due to the lack of established methods. Epigenetic markers, especially DNA methylation, are considered ideal markers for predicting cancer metastasis due to their cancer-specific methylation patterns, biological stability, and technical reproducibility. Our study aims to evaluate methylation of surgical specimens to assess residual disease and predict early recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had histologically confirmed ESCC.
- •Patients who had undergone only complete esophagectomy with radical lymph node dissection without chemotherapy or radiotherapy before or after surgery.
- •Patients for whom tissue samples are available
- •Patients who were followed-up completely, with information on observation periods of at least 2 years after surgery.
- •Written informed consent following full study information is provided to the patient.
排除标准
- •Patients lacking clinical information within 2 years of surgery.
- •Patients with multiple cancers.
研究组 & 干预措施
Patients with postoperative early tumor recurrence with ESCC （Training)
Patients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
干预措施: Surgery (Procedure)
Patients without postoperative early tumor recurrence with ESCC （Training)
Patients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
干预措施: Surgery (Procedure)
Patients with postoperative early tumor recurrence with ESCC （Validation)
Patients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
干预措施: Surgery (Procedure)
Patients without postoperative early tumor recurrence with ESCC （Validation)
Patients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
干预措施: Surgery (Procedure)
结局指标
主要结局
Recurrence-free Survival（RFS)
时间窗: Up to 60 months
Time from curative-intent resection to the development of recurrence (or death)
次要结局
未报告次要终点