Gastric AdenocarcinomaNCT07438418
An Observational Study on Gastric Cancer in High-risk Individuals
An observational study of Gastric Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
This study is designed as a prospective observational cohort study, aiming to assess the differences in the occurrence of gastric cancer and the progression of gastric cancer-related precancerous lesions between individuals who test positive or negative for fecal multi-target testing, with baseline negative gastric… 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
- What is being tested?
- The result of fecal multi-target DNA testing
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 1 Jul 2035
- 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 from communities in Tongling, Anhui Province.
Who may be able to join
- Age ≥ 40 years, gender is not limited.
- Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
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
People's Hospital of Tongling City
Tongling
Guihe Wang, 86-05625838104, 2175613200@qq.com
About this study
Official title: Risk of Gastric Cancer in High-risk Individuals: an Observational Cohort Study
This study is designed as a prospective observational cohort study, aiming to assess the differences in the occurrence of gastric cancer and the progression of gastric cancer-related precancerous lesions between individuals who test positive or negative for fecal multi-target testing, with baseline negative gastric endoscopy results. The clinical outcomes between the two groups will be compared through long-term follow-up.
Read the detailed description
Primary study objective: to compare the differences in gastric cancer incidence between the two groups (individuals who are positive and negative for baseline fecal multi-target testing).
Secondary study objective: to compare the differences in gastric precancerous lesions incidence between the two groups (individuals who are positive and negative for baseline fecal multi-target testing).
- Conditions
- Gastric Adenocarcinoma
- Being tested
- The result of fecal multi-target DNA testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The result of fecal multi-target DNA testingDiagnostic test
By prospectively following individuals who are positive and negative for fecal multi-target testing with baseline negative gastric endoscopy, the incidence of gastric cancer and the progression of gastric precancerous lesions were compared between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Individuals who are positive for baseline fecal multi-target testing Receives: Diagnostic Test: The result of fecal multi-target DNA testing | |
| Conrol | Individuals who are negative for baseline fecal multi-target testing Receives: Diagnostic Test: The result of fecal multi-target DNA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the incidence of gastric cancer during a 3-year follow-up
To compare the difference in the incidence of gastric cancer between groups with positive and negative baseline fecal multi-target testing during a 3-year follow-up.
Measured: During the initial 3-year period of the study
Secondary outcomes (2)
Difference in the incidence of gastric cancer at 5-, and 10-year follow-up time points
To compare the difference in the incidence of gastric cancer between groups with positive and negative baseline fecal multi-target testing at 5-, and 10-year follow-up time points.
Measured: From enrollment to the end of the study in 10 years
Difference in the incidence of precancerous lesions associated with gastric cancer at 3-, 5-, and 10-year follow-up time points
To compare the difference in the incidence of precancerous lesions associated with gastric cancer between groups with positive and negative baseline fecal multi-target testing at 3-, 5-, and 10-year follow-up time points.
Measured: From enrollment to the end of the study in 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start31 Jan 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2035 (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
- 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
- NCT07438418
- Sponsor's protocol ID
- GCA-2026-HRIS
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Gastric Cancer in High-risk Individuals: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07438418
- Acronym / sponsor ID
- GCA-2026-HRIS
- Conditions
- Gastric Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2035 (estimated)
- First posted
- 27 Feb 2026 (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 study is designed as a prospective observational cohort study, aiming to assess the differences in the occurrence of gastric cancer and the progression of gastric cancer-related precancerous lesions between individuals who test positive or negative for fecal multi-target testing, with baseline negative gastric endoscopy results. The clinical outcomes between the two groups will be compared through long-term follow-up.
Detailed description
Primary study objective: to compare the differences in gastric cancer incidence between the two groups (individuals who are positive and negative for baseline fecal multi-target testing).
Secondary study objective: to compare the differences in gastric precancerous lesions incidence between the two groups (individuals who are positive and negative for baseline fecal multi-target testing).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Diagnostic Test: The result of fecal multi-target DNA testingIndividuals who are positive for baseline fecal multi-target testing |
| Conrol | – | Diagnostic Test: The result of fecal multi-target DNA testingIndividuals who are negative for baseline fecal multi-target testing |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were recruited from communities in Tongling, Anhui Province.
Key inclusion criteria (2 listed)
- Age ≥ 40 years, gender is not limited.
- Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
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 |
|---|---|---|
| The result of fecal multi-target DNA testingBy prospectively following individuals who are positive and negative for fecal multi-target testing with baseline negative gastric endoscopy, the incidence of gastric cancer and the progression of gastric precancerous lesions were compared between the two groups. | Diagnostic test | Conrol, Exposure group |
Primary outcome
Difference in the incidence of gastric cancer during a 3-year follow-up
Time frame: During the initial 3-year period of the study
To compare the difference in the incidence of gastric cancer between groups with positive and negative baseline fecal multi-target testing during a 3-year follow-up.
2 secondary outcomes
Difference in the incidence of gastric cancer at 5-, and 10-year follow-up time points
Time frame: From enrollment to the end of the study in 10 years
Difference in the incidence of precancerous lesions associated with gastric cancer at 3-, 5-, and 10-year follow-up time points
Time frame: From enrollment to the end of the study in 10 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 27 Feb 2026.
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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, 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 2 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 27 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?
Difference in the incidence of gastric cancer during a 3-year follow-up (time frame: During the initial 3-year period of the study). 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 27 Feb 2026.