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

NCT05956847 | Recruiting

• 1 other identifier: Gang Ji -3
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer; Precancerous Lesion of Digestive Tract; Extrachromosomal DNA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

gastroscopy PROCEDURE

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

Also known as: Pathological biopsy

Gastric precancerous lesions，Normal gastric mucosal tissue and gastric cancer tissues

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Yuncheng Central Hospital: collaborator
• Xi'an Honghui Hospital: collaborator
• Xi'an No.9 Hospital: collaborator
• Xi'an No.3 Hospital: collaborator
• Xijing 986 Hospital: collaborator

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Gastroscopy biopsy specimen，venous blood，gastric cancer tissue

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei jiangpeng, PhD

CONTACT

15389058362; 15389058362@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 21, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): July 20, 2028
• Study Completion (Estimated): July 30, 2030
• Last Updated: August 29, 2023

Record last verified: 2023-06

Locations

CN (1)