Gastric CancerNCT05956847
The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric
An observational study of Gastric Cancer and Precancerous Lesion of Digestive Tract, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Precancerous Lesion of Digestive Tract, Extrachromosomal DNA
- What is being tested?
- gastroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 30 Jul 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710000
Wei Jiangpeng
About this study
Official title: 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.
- Being tested
- gastroscopy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastroscopyProcedure or surgery
Also called Pathological biopsy
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ecDNA content in different gastric precancerous lesions
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
Measured: 2023/11-2024/11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start10 Aug 2023
- Primary completion20 Jul 2028 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yuncheng Central Hospital, Xi'an Honghui Hospital, Xi'an No.9 Hospital, Xi'an No.3 Hospital, Xijing 986 Hospital
- Responsible party
- Sponsor
- Investigators
- Guo Xin, Principal investigator, Xijing 986 HospitalWang Tongfei, Principal investigator, Xi'an No.3 HospitalHao Junfeng, Principal investigator, Xi'an No.9 HospitalShi Yupeng, Principal investigator, Xi'an Honghui HospitalGao Xiaopeng, Principal investigator, Yuncheng Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956847
- Sponsor's protocol ID
- Gang Ji -3
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric Cancer: an Exploratory Multicenter Prospective Observational Clinical Study
- ClinicalTrials.gov ID
- NCT05956847
- Acronym / sponsor ID
- Gang Ji -3
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Yuncheng Central Hospital, Xi'an Honghui Hospital, Xi'an No.9 Hospital, Xi'an No.3 Hospital, Xijing 986 Hospital
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 20 Jul 2028 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric precancerous lesions，Normal gastric mucosal tissue and gastric cancer tissues | – | Procedure: gastroscopyNormal gastric mucosal tissue Gastric precancerous lesions:Atrophic gastritis, non Atrophic gastritis, intestinal metaplasia, dysplasia gastric cancer tissues |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastroscopyAlso: Pathological biopsyWhen 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 | Procedure or surgery | Gastric precancerous lesions，Normal gastric mucosal tissue and gastric cancer tissues |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guo Xin principal investigator
Xijing 986 Hospital
Wang Tongfei principal investigator
Xi'an No.3 Hospital
Hao Junfeng principal investigator
Xi'an No.9 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Precancerous Lesion of Digestive Tract, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wei jiangpeng, PhD (15389058362, 15389058362@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ecDNA content in different gastric precancerous lesions (time frame: 2023/11-2024/11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.