Gastric AdenocarcinomaNCT06943781
Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection
An observational study of Gastric Adenocarcinoma and Helicobacter Pylori, run by Fudan University at 1 site in China.
Trial summary
This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Adenocarcinoma, Helicobacter Pylori
- What is being tested?
- Fecal Helicobacter pylori gastric cancer susceptibility gene test
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were recruited mainly from communities in Tongling, Anhui Province. The subjects were identified by the investigator based on the enrollment criteria and were informed about the contents of the informed consent form.
Who may be able to join
- Age ≥40 years, male or female.
- No contraindications to endoscopy and able to cooperate with endoscopy.
- Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.
Who cannot join
- A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
- Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- Pregnant or breastfeeding women.
- Other conditions that the investigator deems inappropriate for participation in the study.
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
People's Hospital of Tongling City
Tongling
Guihe Wang, 86-05625838104, 2175613200@qq.com
About this study
Official title: Research on the Application of Fecal Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection in the Early Diagnosis and Screening of Gastric Cancer
This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.
Read the detailed description
Sample Selection:
The study will be conducted in selected communities within Tongling City, with a total of 10000-15000 residents recruited.
Participants Recruitment:
- Participation is voluntary. All subjects must provide written informed consent at the time of recruitment.
- Well-trained investigators will conduct face-to-face interviews to administer the gastric cancer risk questionnaire.
Tests and Follow-up:
- Initial Screening: All participants will provide a stool sample for fecal H. pylori gastric cancer susceptibility testing and complete a questionnaire.
- Definition of Screening Positive: A participant will be considered screening positive if they test positive on the H. pylori gastric cancer susceptibility testing or are identified as high-risk through the questionnaire.
- Diagnostic Workup: All screening-positive individuals will be referred for a confirmatory diagnostic workup. Briefly, the endoscopist will conduct a fiberoptic endoscopy and perform a pathological biopsy.
- Follow-up: Screening-positive individuals who are not diagnosed with gastric cancer in the first year will be entered into an annual follow-up program.
- Biobanking: Residual fecal samples will be stored at the biobank of Fudan University Shanghai Cancer Center for future biomarker research.
- Conditions
- Gastric Adenocarcinoma, Helicobacter Pylori
- Being tested
- Fecal Helicobacter pylori gastric cancer susceptibility gene test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Helicobacter pylori gastric cancer susceptibility gene testDiagnostic test
In the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer and the low-risk group. The status of the SNP locus was detected in portable and non-invasive fecal samples from participants using molecular biology assays for early non-invasive screening and risk assessment of gastric cancer in H. pylori infected patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer
To compare the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer.
Measured: 2 years
Secondary outcomes (3)
Positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer
To compare the positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening methods for gastric cancer
Measured: 2 years
Number needed to screen to identify one gastric cancer
To compare the number of participants needed to screen identify one gastric cancer for different methods
Measured: 2 years
Early diagnosis rate of gastric cancer
To compare the early gastric cancer detection rate achieved by the fecal H. pylori gastric cancer susceptibility testing and the questionnaire screening.
Measured: 2 years
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 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 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 AdenocarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 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
- NCT06943781
- Sponsor's protocol ID
- 2410-Exp081
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of Fecal Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection in the Early Diagnosis and Screening of Gastric Cancer
- ClinicalTrials.gov ID
- NCT06943781
- Acronym / sponsor ID
- 2410-Exp081
- Conditions
- Gastric Adenocarcinoma, Helicobacter Pylori
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (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 prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.
Detailed description
Sample Selection:
The study will be conducted in selected communities within Tongling City, with a total of 10000-15000 residents recruited.
Participants Recruitment:
- Participation is voluntary. All subjects must provide written informed consent at the time of recruitment.
- Well-trained investigators will conduct face-to-face interviews to administer the gastric cancer risk questionnaire.
Tests and Follow-up:
- Initial Screening: All participants will provide a stool sample for fecal H. pylori gastric cancer susceptibility testing and complete a questionnaire.
- Definition of Screening Positive: A participant will be considered screening positive if they test positive on the H. pylori gastric cancer susceptibility testing or are identified as high-risk through the questionnaire.
- Diagnostic Workup: All screening-positive individuals will be referred for a confirmatory diagnostic workup. Briefly, the endoscopist will conduct a fiberoptic endoscopy and perform a pathological biopsy.
- Follow-up: Screening-positive individuals who are not diagnosed with gastric cancer in the first year will be entered into an annual follow-up program.
- Biobanking: Residual fecal samples will be stored at the biobank of Fudan University Shanghai Cancer Center for future biomarker research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were recruited mainly from communities in Tongling, Anhui Province. The subjects were identified by the investigator based on the enrollment criteria and were informed about the contents of the informed consent form.
Key inclusion criteria (3 listed)
- Age ≥40 years, male or female.
- No contraindications to endoscopy and able to cooperate with endoscopy.
- Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.
Key exclusion criteria (5 listed)
- A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
- Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- Pregnant or breastfeeding women.
- Other conditions that the investigator deems inappropriate for participation in the study.
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 Helicobacter pylori gastric cancer susceptibility gene testIn the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer and the low-risk group. The status of the SNP locus was detected in portable and non-invasive fecal samples from participants using molecular biology assays for early non-invasive screening and risk assessment of gastric cancer in H. pylori infected patients. | Diagnostic test | – |
Primary outcome
Sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer
Time frame: 2 years
To compare the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer.
3 secondary outcomes
Positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer
Time frame: 2 years
Number needed to screen to identify one gastric cancer
Time frame: 2 years
Early diagnosis rate of gastric cancer
Time frame: 2 years
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 25 Feb 2026.
- 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.
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 Adenocarcinoma and Helicobacter Pylori, 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. 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 Dazhi Xu, PhD (86-18121299796, xudzh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer (time frame: 2 years). 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 25 Feb 2026.