The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric Cancer: an Exploratory Multicenter Prospective Observational Clinical Study

Conditions
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Gastric Cancer, Precancerous Lesion of Digestive Tract, Extrachromosomal DNA

Intervention / Treatment
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* Procedure: gastroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric precancerous lesions，Normal gastric mucosal tissue and gastric cancer tissues<br>Normal gastric mucosal tissue Gastric precancerous lesions:Atrophic gastritis, non Atrophic gastritis, intestinal metaplasia, dysplasia gastric cancer tissues | Procedure: gastroscopy<br>* When performing gastroscopy, the endoscopist will perform a biopsy based on the condition of gastric mucosal lesions, with one specimen retained and the remaining specimens subjected to pathological examination<br>* Other names: Pathological biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ecDNA content in different gastric precancerous lesions | 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 | 2023/11-2024/11 |