The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: gastroscopy.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Precancerous Lesion of Digestive Tract, Extrachromosomal DNA. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric Cancer: an Exploratory Multicenter Prospective Observational Clinical Study
Overview
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
- 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
Primary outcome measures
- Changes in ecDNA content in different gastric precancerous lesions [Time frame: 2023/11-2024/11]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion Criteria：
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xijing Hospital of Digestive Diseases — Xi'an
Identifiers
NCT: NCT05956847 · Gang Ji -3