The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric Cancer: an Exploratory Multicenter Prospective Observational Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Changes in ecDNA content in different gastric precancerous lesions
研究概览
简要总结
ECDNA is almost non-existent in normal cells, but exists in nearly half of human cancer cells, indicating that studying such abnormal DNA is of great significance for our understanding of tumor formation and evolution. The changes in ecDNA expression in intestinal type gastric cancer may be closely related to the occurrence and development of gastric cancer. Dynamic monitoring of changes in ecDNA expression in the gastric mucosa may help predict the occurrence of gastric cancer and guide subsequent treatment. By collaborating with multiple endoscopic centers to conduct gastroscopy biopsies on patients with gastric precancerous lesions, we aim to further explore the role of ecDNA in the occurrence and development of gastric cancer through continuous follow-up.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-80 years old;
- •Patients who plan to undergo gastroscopy at the endoscopic center and patients who undergo surgical treatment for gastric adenocarcinoma;
- •Endoscopy doctors believe that pathological biopsy is necessary to clarify the pathological diagnosis;
- •No serious diseases or other systemic malignancies in terms of physical and mental health;
- •More than one item of non Atrophic gastritis, Atrophic gastritis, intestinal metaplasia, heterogeneous hyperplasia (low grade intraepithelial neoplasia and high grade intraepithelial neoplasia), and gastric adenocarcinoma;
- •Sign an informed consent form;
- •Exclusion Criteria：
- •Pathological results indicate other malignant tumors of the stomach, such as stromal tumors and lymphoma;
- •The patient and their family members do not agree to use the specimen for later research projects;
- •Before gastroscopy or surgery, neoadjuvant therapy or combined with other malignant tumors;
- •Non R0 resected gastric cancer patients;
- •Pregnant or lactating women;
- •Have a history of drug abuse such as alcohol and tobacco.
排除标准
- 未提供
结局指标
主要结局
Changes in ecDNA content in different gastric precancerous lesions
时间窗: 2023/11-2024/11
Compare the differences in ecDNA in gastric mucosal tissue at different stages of gastric precancerous lesions, and explore the role of ecDNA in disease progression after 5 years of follow-up
次要结局
未报告次要终点