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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956847
• Other study ID #: Gang Ji -3
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: July 30, 2030

Study information

• Verified date: June 2023
• Source: Xijing Hospital
• Contact: wei jiangpeng, PhD
• Phone: 15389058362
• Email: 15389058362[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 30, 2030
• Est. primary completion date: July 20, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
Xijing Hospital	Xi'an Honghui Hospital, Xi'an No.3 Hospital, Xi'an No.9 Hospital, Xijing 986 Hospital, Yuncheng Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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