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NCT Number: NCT05956847

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Extrachromosomal DNA Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Precancerous Lesion of Digestive Tract Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710000, China

Location status: Recruiting

Location contact

Wei Jiangpeng

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Pathological biopsy

Primary outcomes

  1. Changes in ecDNA content in different gastric precancerous lesions

    Time frame: 2023/11-2024/11

    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

Study contacts

Contact information is provided by the study sponsor or research team.

wei jiangpeng, PhD

CONTACT

[email protected]

15389058362

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

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

Registry information

Official study title

The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric Cancer: an Exploratory Multicenter Prospective Observational Clinical Study

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Jul 21, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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