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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05956847
Enrollment
1000
Registered
2023-07-21
Start date
2023-08-10
Completion date
2030-07-30
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extrachromosomal DNA, Gastric Cancer, Precancerous Lesion of Digestive Tract

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.

Interventions

PROCEDUREgastroscopy

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

Sponsors

Yuncheng Central Hospital
CollaboratorOTHER
Xi'an Honghui Hospital
CollaboratorOTHER
Xi'an No.9 Hospital
CollaboratorUNKNOWN
Xi'an No.3 Hospital
CollaboratorOTHER_GOV
Xijing 986 Hospital
CollaboratorUNKNOWN
Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in ecDNA content in different gastric precancerous lesions2023/11-2024/11Compare 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

Countries

China

Contacts

Primary Contactwei jiangpeng, PhD
15389058362@163.com15389058362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026