Methylation Analysis of Circulating Tumor DNA in Early Diagnosis and Prognostic Stratification in Patients With Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 主要终点
- Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer.
研究概览
简要总结
The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.
详细描述
Gastric cancer represents one of the common malignant tumors in China, with high incidence and mortality rates. Surgery is the conventional treatment option for early and intermediate stage gastric cancer, but the diagnosis in the early stage of gastric cancer remains a challenge to clinical practitioners. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell-free DNA (cfDNA) of other sources in blood circulation. ctDNA is reflecting the most up-to-date status of the tumor genome. Hence, it is considered as a novel biomarker for tumors, which can be qualitative, quantitative, and used for disease monitoring. This study is designed to evaluate the potential clinical utility of circulating tumor DNA (ctDNA) as a clinical index in the diagnosis and prognosis of gastric cancer. The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is scheduled to undergo an endoscopy because of medical indications.
- •The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
- •The subject must be willing and able to comply with all study procedures.
排除标准
- •The subject who is unable to undergo gastroscopy.
- •The subject with previous total or partial gastrectomy.
- •The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study.
- •The subject is unwilling or unable to provide signed informed consent.
- •The subject who is pregnant.
结局指标
主要结局
Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer.
时间窗: 1-2 years
We will develop the linear model and a threshold value differentiating gastric cancer from control based on the 100 patient training set.
次要结局
未报告次要终点