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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Precancerous Lesion of Digestive Tract; Extrachromosomal DNA
• Intervention / Treatment: Procedure: gastroscopy

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: wei jiangpeng, PhD; Phone Number: 15389058362; Email: 15389058362@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • Xijing Hospital of Digestive Diseases
      • Contact: Wei Jiangpeng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The population included in this study is mainly healthy patients who underwent gastroscopy at endoscopic centers, some of whom may develop gastric cancer during follow-up. At the same time, we will collect mucosal samples from volunteers who underwent gastroscopy but had normal gastric mucosa, and we will also collect gastric cancer tissue samples after surgical resection in our department

Description

Inclusion Criteria:

1. Age: 18-80 years old;
2. Patients who plan to undergo gastroscopy at the endoscopic center and patients who undergo surgical treatment for gastric adenocarcinoma;
3. Endoscopy doctors believe that pathological biopsy is necessary to clarify the pathological diagnosis;
4. No serious diseases or other systemic malignancies in terms of physical and mental health;
5. 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;
6. Sign an informed consent form;

Exclusion Criteria：

1. Pathological results indicate other malignant tumors of the stomach, such as stromal tumors and lymphoma;
2. The patient and their family members do not agree to use the specimen for later research projects;
3. Before gastroscopy or surgery, neoadjuvant therapy or combined with other malignant tumors;
4. Non R0 resected gastric cancer patients;
5. Pregnant or lactating women;
6. Have a history of drug abuse such as alcohol and tobacco.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastric precancerous lesions，Normal gastric mucosal tissue and gastric cancer tissues; Normal gastric mucosal tissue Gastric precancerous lesions:Atrophic gastritis, non Atrophic gastritis, intestinal metaplasia, dysplasia gastric cancer tissues	Procedure: gastroscopy; 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; Other Names: Pathological biopsy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Xi'an No.3 Hospital; Xi'an Honghui Hospital; Yuncheng Central Hospital; Xi'an No.9 Hospital; Xijing 986 Hospital
• Investigators: Principal Investigator: Guo Xin, Xijing 986 Hospital; Principal Investigator: Wang Tongfei, Xi'an No.3 Hospital; Principal Investigator: Hao Junfeng, Xi'an No.9 Hospital; Principal Investigator: Shi Yupeng, Xi'an Honghui Hospital; Principal Investigator: Gao Xiaopeng, Yuncheng Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): July 20, 2028
• Study Completion (Estimated): July 30, 2030

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: Gang Ji -3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No