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

NCT ID: NCT05956847

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2030-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Precancerous Lesion of Digestive Tract Extrachromosomal DNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric precancerous lesions,Normal gastric mucosal tissue and gastric cancer tissues

Normal gastric mucosal tissue Gastric precancerous lesions:Atrophic gastritis, non Atrophic gastritis, intestinal metaplasia, dysplasia gastric cancer tissues

gastroscopy

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Pathological biopsy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuncheng Central Hospital

OTHER

Sponsor Role collaborator

Xi'an Honghui Hospital

OTHER

Sponsor Role collaborator

Xi'an No.9 Hospital

UNKNOWN

Sponsor Role collaborator

Xi'an No.3 Hospital

OTHER_GOV

Sponsor Role collaborator

Xijing 986 Hospital

UNKNOWN

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guo Xin

Role: PRINCIPAL_INVESTIGATOR

Xijing 986 Hospital

Wang Tongfei

Role: PRINCIPAL_INVESTIGATOR

Xi'an No.3 Hospital

Hao Junfeng

Role: PRINCIPAL_INVESTIGATOR

Xi'an No.9 Hospital

Shi Yupeng

Role: PRINCIPAL_INVESTIGATOR

Xi'an Honghui Hospital

Gao Xiaopeng

Role: PRINCIPAL_INVESTIGATOR

Yuncheng Central Hospital

Locations

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Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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wei jiangpeng, PhD

Role: CONTACT

15389058362

Facility Contacts

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Wei Jiangpeng

Role: primary

Other Identifiers

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Gang Ji -3

Identifier Type: -

Identifier Source: org_study_id

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