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Trial Title:
The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric
NCT ID:
NCT05956847
Condition:
Gastric Cancer
Precancerous Lesion of Digestive Tract
Extrachromosomal DNA
Conditions: Official terms:
Stomach Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
gastroscopy
Description:
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
Arm group label:
Gastric precancerous lesions，Normal gastric mucosal tissue and gastric cancer tissues
Other name:
Pathological biopsy
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Xijing Hospital of Digestive Diseases
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Jiangpeng
Start date:
August 10, 2023
Completion date:
July 30, 2030
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Collaborator:
Agency:
Yuncheng Central Hospital
Agency class:
Other
Collaborator:
Agency:
Xi'an Honghui Hospital
Agency class:
Other
Collaborator:
Agency:
Xi'an No.9 Hospital
Agency class:
Other
Collaborator:
Agency:
Xi'an No.3 Hospital
Agency class:
Other
Collaborator:
Agency:
Xijing 986 Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05956847
