Gastric (Stomach) CancerNCT06943807
Prospective Gastric Cancer Screening With Fecal Multi-target DNA Analysis
An observational study of Gastric (Stomach) Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective study designed to evaluate the efficacy of a multi-target fecal DNA test for the early detection of gastric cancer. The test combines Helicobacter pylori gene detection with analysis of fecal methylated DNA markers. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric (Stomach) Cancer
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 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 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: A Prospective Study of Gastric Cancer Screening Based on Fecal Multi-Target DNA Analysis Combined With a Risk Questionnaire
This is a prospective study designed to evaluate the efficacy of a multi-target fecal DNA test for the early detection of gastric cancer. The test combines Helicobacter pylori gene detection with analysis of fecal methylated DNA markers. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo the multi-target fecal DNA test 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 the multi-target DNA analysis (including H. pylori susceptibility testing and methylated DNA markers) and complete a questionnaire.
- Definition of Screening Positive: A participant will be considered screening positive if they test positive on the fecal multi-target DNA test 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 (Stomach) Cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer
To compare the sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer.
Measured: 2 years
Secondary outcomes (4)
Positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
To compare the positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
Measured: 2 years
Number needed to screen to identify one gastric cancer
To calculate and compare the number of participants needed to screen to identify one case of gastric cancer using the fecal DNA test versus the questionnaire.
Measured: 2 years
Early diagnosis rate of gastric cancer
To compare the early gastric cancer detection rate achieved by the fecal multi-target DNA testing and the questionnaire.
Measured: 2 years
Diagnosis rate of precancerous lesions associated with gastric cancer
To compare the detection rate of the fecal multi-target DNA testing and the questionnaire for precancerous lesions associated with gastric cancer
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 completion30 Aug 2026 (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
- 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
- NCT06943807
- Sponsor's protocol ID
- 2410-Exp079
- 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
- A Prospective Study of Gastric Cancer Screening Based on Fecal Multi-Target DNA Analysis Combined With a Risk Questionnaire
- ClinicalTrials.gov ID
- NCT06943807
- Acronym / sponsor ID
- 2410-Exp079
- Conditions
- Gastric (Stomach) Cancer
- 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
- 30 Aug 2026 (estimated)
- Study completion
- 30 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 evaluate the efficacy of a multi-target fecal DNA test for the early detection of gastric cancer. The test combines Helicobacter pylori gene detection with analysis of fecal methylated DNA markers. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo the multi-target fecal DNA test 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 the multi-target DNA analysis (including H. pylori susceptibility testing and methylated DNA markers) and complete a questionnaire.
- Definition of Screening Positive: A participant will be considered screening positive if they test positive on the fecal multi-target DNA test 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.
Primary outcome
Sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer
Time frame: 2 years
To compare the sensitivity and specificity of the fecal multi-target DNA test and questionnaire screening for gastric cancer.
4 secondary outcomes
Positive and negative predictive values of the fecal multi-target DNA test and the questionnaire screening method
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
Diagnosis rate of precancerous lesions associated with 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
Related trials for Gastric (Stomach) Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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 (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: 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 the fecal multi-target DNA test and questionnaire screening 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.