Gastric (Stomach) CancerNCT07312500
Fecal DNA Methylation and Helicobacter Pylori SNPs Tests for Gastric Cancer
An observational study of Gastric (Stomach) Cancer, run by Fudan University at 1 site in China.
Trial summary
Based on the detection technology of methylation sites in feces, combined or not combined with Helicobacter pylori gastric cancer susceptibility gene detection, an early diagnosis and detection system for gastric cancer is established, and the clinical diagnostic value of the detection system is evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric (Stomach) Cancer
- What is being tested?
- Diagnostic Test: fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects for this clinical study were obtained from inpatients and outpatient follow-up patients attending the sub-center. Subjects will be identified by the investigator based on subject entry criteria and informed of the contents of the informed consent form. Subjects will have their feces collected at the time of clinic visit or at the time of physical examination and will be tested for fecal methylated DNA and H. pylori gastric cancer susceptibility genes.
Who may be able to join
- Age ≥ 18 years old, male or female not limited.
- Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer.
- Patients must be able to fully understand the informed consent form and be able to personally sign it.
Who cannot join
- Severe heart, liver, kidney dysfunction, or mental illness.
- History of malignant tumors in the upper gastrointestinal tract.
- Pregnant women.
- Those with unclear pathology.
- Those with unsatisfactory sample retention (such as insufficient sample size).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Fecal DNA Methylation and Fecal Helicobacter Pylori Gastric Cancer Susceptibility Genes in Clinical Diagnosis, Treatment, and Relapse and Metastasis of Gastric Cancer
Based on the detection technology of methylation sites in feces, combined or not combined with Helicobacter pylori gastric cancer susceptibility gene detection, an early diagnosis and detection system for gastric cancer is established, and the clinical diagnostic value of the detection system is evaluated. In addition, the study observed the association between different loci and post-treatment recurrence, metastasis, or long-term survival rate through long-term follow-up of gastric cancer patients; Follow up with individuals with benign diseases such as gastritis and healthy individuals, compare cases of gastric cancer, and compare their sample data during follow-up with controls who did not have the disease.
- Conditions
- Gastric (Stomach) Cancer
- Being tested
- Diagnostic Test: fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testingDiagnostic test
To establish an early diagnostic test system for gastric cancer based on the methylation site detection technology in feces, with or without the combination of Helicobacter pylori gastric cancer susceptibility gene detection, and then to evaluate the clinical diagnostic value of this test system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of early diagnosis of gastric cancer
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric (Stomach) CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312500
- Sponsor's protocol ID
- 2410-Exp092-02
- Status last verified
- Dec 2025
- First submitted
- 21 Jun 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Fecal DNA Methylation and Fecal Helicobacter Pylori Gastric Cancer Susceptibility Genes in Clinical Diagnosis, Treatment, and Relapse and Metastasis of Gastric Cancer
- ClinicalTrials.gov ID
- NCT07312500
- Acronym / sponsor ID
- 2410-Exp092-02
- Conditions
- Gastric (Stomach) Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 Dec 2025 (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.
Based on the detection technology of methylation sites in feces, combined or not combined with Helicobacter pylori gastric cancer susceptibility gene detection, an early diagnosis and detection system for gastric cancer is established, and the clinical diagnostic value of the detection system is evaluated. In addition, the study observed the association between different loci and post-treatment recurrence, metastasis, or long-term survival rate through long-term follow-up of gastric cancer patients; Follow up with individuals with benign diseases such as gastritis and healthy individuals, compare cases of gastric cancer, and compare their sample data during follow-up with controls who did not have the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects for this clinical study were obtained from inpatients and outpatient follow-up patients attending the sub-center. Subjects will be identified by the investigator based on subject entry criteria and informed of the contents of the informed consent form. Subjects will have their feces collected at the time of clinic visit or at the time of physical examination and will be tested for fecal methylated DNA and H. pylori gastric cancer susceptibility genes.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old, male or female not limited.
- Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer.
- Patients must be able to fully understand the informed consent form and be able to personally sign it.
Key exclusion criteria (5 listed)
- Severe heart, liver, kidney dysfunction, or mental illness.
- History of malignant tumors in the upper gastrointestinal tract.
- Pregnant women.
- Those with unclear pathology.
- Those with unsatisfactory sample retention (such as insufficient sample size).
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 |
|---|---|---|
| Diagnostic Test: fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testingTo establish an early diagnostic test system for gastric cancer based on the methylation site detection technology in feces, with or without the combination of Helicobacter pylori gastric cancer susceptibility gene detection, and then to evaluate the clinical diagnostic value of this test system. | Diagnostic test | – |
Primary outcome
Positive predictive value of early diagnosis of gastric cancer
Time frame: baseline
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 31 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (Stomach) Cancer, run by Fudan University 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value of early diagnosis of gastric cancer (time frame: baseline). 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 31 Dec 2025.