Clinical trial NCT05956847: The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric
Official title: The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric Cancer: an Exploratory Multicenter Prospective Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Precancerous Lesion of Digestive Tract
Extrachromosomal DNA
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Yuncheng Central Hospital
name: Xi'an Honghui Hospital
name: Xi'an No.9 Hospital
name: Xi'an No.3 Hospital
name: Xijing 986 Hospital
First posted: 2023-07-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: Changes in ecDNA content in different gastric precancerous lesions
timeFrame: 2023/11-2024/11
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Xijing 986 Hospital
name: Guo Xin
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi'an No.3 Hospital
name: Wang Tongfei
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi'an No.9 Hospital
name: Hao Junfeng
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi'an Honghui Hospital
name: Shi Yupeng
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuncheng Central Hospital
name: Gao Xiaopeng
role: PRINCIPAL_INVESTIGATOR
References: