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

August 27, 2023 updated by: Xijing Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Recruiting
        • Xijing Hospital of Digestive Diseases
        • Contact:
          • Wei Jiangpeng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
Other Names:
  • Pathological biopsy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2023/11-2024/11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xi'an No.3 Hospital
Xi'an Honghui Hospital
Yuncheng Central Hospital
Xi'an No.9 Hospital
Xijing 986 Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guo Xin, Xijing 986 Hospital
  • Principal Investigator: Wang Tongfei, Xi'an No.3 Hospital
  • Principal Investigator: Hao Junfeng, Xi'an No.9 Hospital
  • Principal Investigator: Shi Yupeng, Xi'an Honghui Hospital
  • Principal Investigator: Gao Xiaopeng, Yuncheng Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gang Ji -3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings