Gastric (Stomach) CancerNCT06943768
Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test
An observational study of Gastric (Stomach) Cancer, run by Fudan University.
Trial summary
This is a multicenter, cross-sectional study. It is based on fecal methylation site detection, H. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, CT, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and… 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?
- fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing
- How many people
- 9,654 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Jun 2026
- 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: The subjects of this clinical study are from the community population in the high incidence area of gastric cancer in Tongling. The subjects will collect feces during medical visits or physical examinations, and undergo fecal methylation DNA and Helicobacter pylori gastric cancer susceptibility gene testing. The researchers determine the study subjects based on the inclusion and exclusion criteria and inform them of the content of the informed consent form.
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 cardiac, hepatic, or renal insufficiency, or psychiatric disorders.
- A previous history of malignant tumors of the upper gastrointestinal tract.
- Women during pregnancy.
- Those with undefined pathology.
- Those with unsatisfactory sample retention (e.g., too small a sample size)
About this study
Official title: Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes for the Early Diagnosis and Screening of Gastric Cancer
This is a multicenter, cross-sectional study. It is based on fecal methylation site detection, H. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, CT, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and health check-ups.
Read the detailed description
Primary study objective: to evaluate the sensitivity and specificity of fecal methylation site-based and fecal Helicobacter pylori gastric cancer susceptibility gene assays applied to early diagnosis and screening of gastric cancer.
Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, and negative predictive value of fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing applied for predicting gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumor markers, such as CA19-9, CEA, and CA72-4; and 3. the follow up of Gastritis and healthy people, to assess the cases of gastric cancer during the follow-up period and the clinical diagnosis and treatment prediction; 4. Follow-up gastric cancer patients, to assess the association with gastric cancer recurrence metastasis and treatment.
- Conditions
- Gastric (Stomach) Cancer
- Being tested
- 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.
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.
Sensitivity and specificity
Sensitivity and specificity of fecal DNA methylation detection and Helicobacter pylori gastric cancer susceptibility genes based on their application for early diagnosis and screening 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 posted24 Apr 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (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
- 9,654 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
- NCT06943768
- Sponsor's protocol ID
- 2410-Exp092
- Status last verified
- Nov 2024
- First submitted
- 20 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes for the Early Diagnosis and Screening of Gastric Cancer
- ClinicalTrials.gov ID
- NCT06943768
- Acronym / sponsor ID
- 2410-Exp092
- Conditions
- Gastric (Stomach) Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 9,654 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Apr 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.
This is a multicenter, cross-sectional study. It is based on fecal methylation site detection, H. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, CT, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and health check-ups.
Detailed description
Primary study objective: to evaluate the sensitivity and specificity of fecal methylation site-based and fecal Helicobacter pylori gastric cancer susceptibility gene assays applied to early diagnosis and screening of gastric cancer.
Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, and negative predictive value of fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing applied for predicting gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumor markers, such as CA19-9, CEA, and CA72-4; and 3. the follow up of Gastritis and healthy people, to assess the cases of gastric cancer during the follow-up period and the clinical diagnosis and treatment prediction; 4. Follow-up gastric cancer patients, to assess the association with gastric cancer recurrence metastasis and treatment.
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
- The subjects of this clinical study are from the community population in the high incidence area of gastric cancer in Tongling. The subjects will collect feces during medical visits or physical examinations, and undergo fecal methylation DNA and Helicobacter pylori gastric cancer susceptibility gene testing. The researchers determine the study subjects based on the inclusion and exclusion criteria and inform them of the content of the informed consent form.
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 cardiac, hepatic, or renal insufficiency, or psychiatric disorders.
- A previous history of malignant tumors of the upper gastrointestinal tract.
- Women during pregnancy.
- Those with undefined pathology.
- Those with unsatisfactory sample retention (e.g., too small a 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 |
|---|---|---|
| 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
Sensitivity and specificity
Time frame: Baseline
Sensitivity and specificity of fecal DNA methylation detection and Helicobacter pylori gastric cancer susceptibility genes based on their application for early diagnosis and screening of gastric cancer.
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 24 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric (Stomach) Cancer, run by Fudan University.
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: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity and specificity (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 24 Jun 2025.