Gastric CancerNCT07782294
AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis
An observational study of Gastric Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial summary
The goal of this clinical trial is to prospectively validate the diagnostic performance of an rbcDNA-based assay for gastric cancer detection in individuals undergoing upper gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- Type of treatment
- Injection or infusion
- How many people
- 542 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2026to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants consist of patients with gastric diseases undergoing gastroscopy, enrolled from three different medical centers across China.
Who may be able to join
- Age between 18 and 75 years.
- Scheduled for upper gastrointestinal endoscopy for the assessment of gastric diseases, including gastric cancer (stage I-IV), gastric precancerous lesions, and other benign gastric disorders.
- No previous treatment for the current gastric disease prior to blood collection, including surgery, chemotherapy, radiotherapy, immunotherapy and other anti-tumor therapies.
- Able and willing to participate and provide written informed consent. Exclusion Criteria
- Receiving therapeutic gastroscopy or endoscopic resection for gastric lesions diagnosed in other institutions.
- Presence of conditions that hinder complete gastric endoscopic visualization and reliable lesion evaluation, such as gastric retention and severe esophageal stenosis.
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- History of other malignant tumors, prior anti-tumor treatment, or partial/total gastrectomy.
- Severe hemodynamic instability, malignant arrhythmia, unstable cardiovascular diseases, or recent major surgery.
- Hematological disorders, recent blood transfusion history, severe active infection, chronic infectious diseases (e.g., HIV), or severe systemic inflammation affecting blood cell composition.
- Pregnant or breastfeeding women.
- Enrolled in other concurrent clinical trials that may affect the current study results.
- Refusal to sign informed consent or failure to comply with study procedures.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Anyang Tumor Hospital
Anyang, Henan, 455000
Ganshu Xia, +86 15137256517, xgsmed2015@163.com
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Yuehua Han, +86 13858126927, 13858126927@163.com
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200001
Xiao Liang, +86 13816772126, liangxmd@hotmail.com
About this study
Official title: Application Research of Artificial Intelligence-Assisted Novel Red Blood Cell DNA (rbcDNA) Detection for Early Diagnosis of Gastric Cancer
The goal of this clinical trial is to prospectively validate the diagnostic performance of an rbcDNA-based assay for gastric cancer detection in individuals undergoing upper gastrointestinal endoscopy. The study aims to evaluate the diagnostic accuracy of rbcDNA in distinguishing newly diagnosed, treatment-naïve gastric cancer from non-cancerous gastric conditions, using endoscopic and histopathological findings as the reference standard. The study will also compare the diagnostic performance of the rbcDNA-based approach with currently available clinical biomarkers, including serum tumor markers, Helicobacter pylori testing, and pepsinogen-related indices.
All enrolled participants will provide a 2 mL peripheral blood sample for rbcDNA analysis.
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, rbcDNA, Early detection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GC group | Subjects with histopathologically confirmed gastric cancer (stage I-IV) | |
| Contol group | Non-gastric cancer subjects, including superficial gastritis, gastric ulcer, adenomatous gastric polyps, atrophic gastritis, intestinal metaplasia, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the rbcDNA blood test for gastric cancer screening
Sensitivity is defined as the percentage of participants with pathologically confirmed gastric cancer who have a positive rbcDNA test result. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation. Higher sensitivity indicates fewer true gastric cancer cases are missed by the test.
Measured: Through study completion, an average of 1 year
Specificity of the rbcDNA blood test for gastric cancer screening
Specificity is defined as the percentage of participants without gastric cancer (with other benign gastric disorders) who have a negative rbcDNA test result. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation. Higher specificity indicates fewer false-positive test results.
Measured: Through study completion, an average of 1 year
Overall accuracy of the rbcDNA blood test for gastric cancer screening
Overall accuracy is defined as the percentage of all enrolled participants whose rbcDNA test result matches the final clinical-pathological gastric disease diagnosis. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Sensitivity of conventional gastric cancer screening tests
Percent of pathologically-confirmed gastric cancer participants with positive results from conventional screening assays, including serum tumor markers, Helicobacter pylori testing and pepsin-related indices. Calculated against final pathological gastric cancer diagnosis as unified gold standard.
Measured: Through study completion, an average of 1 year
Specificity of conventional clinical gastric cancer screening tests
Percent of participants without pathologically-confirmed gastric cancer with negative results from conventional screening assays, including serum tumor markers, Helicobacter pylori testing and pepsin-related indices. Calculated against final pathological gastric cancer diagnosis as unified gold standard.
Measured: Through study completion, an average of 1 year
Overall accuracy of conventional clinical gastric cancer screening tests
Proportion of all participants with consistent results from conventional screening assays relative to final pathological gastric cancer diagnosis (unified gold-standard reference). Conventional assays include serum tumor markers, Helicobacter pylori testing and pepsin-related indices.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 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 CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Prospective
- Enrolment
- 542 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Anyang Tumor Hospital, RenJi Hospital
- Responsible party
- Sponsor
- Investigators
- Yuehua Han, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782294
- Sponsor's protocol ID
- 2026-0523
- Status last verified
- May 2026
- First submitted
- 29 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to intellectual property protection of rbcDNA detection technology, restrictions from institutional ethics and informed consent of participants.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Research of Artificial Intelligence-Assisted Novel Red Blood Cell DNA (rbcDNA) Detection for Early Diagnosis of Gastric Cancer
- ClinicalTrials.gov ID
- NCT07782294
- Acronym / sponsor ID
- 2026-0523
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, rbcDNA, Early detection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 542 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Anyang Tumor Hospital, RenJi Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Aug 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.
The goal of this clinical trial is to prospectively validate the diagnostic performance of an rbcDNA-based assay for gastric cancer detection in individuals undergoing upper gastrointestinal endoscopy. The study aims to evaluate the diagnostic accuracy of rbcDNA in distinguishing newly diagnosed, treatment-naïve gastric cancer from non-cancerous gastric conditions, using endoscopic and histopathological findings as the reference standard. The study will also compare the diagnostic performance of the rbcDNA-based approach with currently available clinical biomarkers, including serum tumor markers, Helicobacter pylori testing, and pepsinogen-related indices.
All enrolled participants will provide a 2 mL peripheral blood sample for rbcDNA analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC group | – | –Subjects with histopathologically confirmed gastric cancer (stage I-IV) |
| Contol group | – | –Non-gastric cancer subjects, including superficial gastritis, gastric ulcer, adenomatous gastric polyps, atrophic gastritis, intestinal metaplasia, etc. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants consist of patients with gastric diseases undergoing gastroscopy, enrolled from three different medical centers across China.
Key inclusion criteria (12 listed)
- Age between 18 and 75 years.
- Scheduled for upper gastrointestinal endoscopy for the assessment of gastric diseases, including gastric cancer (stage I-IV), gastric precancerous lesions, and other benign gastric disorders.
- No previous treatment for the current gastric disease prior to blood collection, including surgery, chemotherapy, radiotherapy, immunotherapy and other anti-tumor therapies.
- Able and willing to participate and provide written informed consent. Exclusion Criteria
- Receiving therapeutic gastroscopy or endoscopic resection for gastric lesions diagnosed in other institutions.
Key exclusion criteria (0 listed)
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 of the rbcDNA blood test for gastric cancer screening
Time frame: Through study completion, an average of 1 year
Sensitivity is defined as the percentage of participants with pathologically confirmed gastric cancer who have a positive rbcDNA test result. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation. Higher sensitivity indicates fewer true gastric cancer cases are missed by the test.
Specificity of the rbcDNA blood test for gastric cancer screening
Time frame: Through study completion, an average of 1 year
Specificity is defined as the percentage of participants without gastric cancer (with other benign gastric disorders) who have a negative rbcDNA test result. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation. Higher specificity indicates fewer false-positive test results.
Overall accuracy of the rbcDNA blood test for gastric cancer screening
Time frame: Through study completion, an average of 1 year
Overall accuracy is defined as the percentage of all enrolled participants whose rbcDNA test result matches the final clinical-pathological gastric disease diagnosis. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation.
3 secondary outcomes
Sensitivity of conventional gastric cancer screening tests
Time frame: Through study completion, an average of 1 year
Specificity of conventional clinical gastric cancer screening tests
Time frame: Through study completion, an average of 1 year
Overall accuracy of conventional clinical gastric cancer screening tests
Time frame: Through study completion, an average of 1 year
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 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to intellectual property protection of rbcDNA detection technology, restrictions from institutional ethics and informed consent of participants.
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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.
Yuehua Han study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites 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 12 inclusion and 0 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Yuehua Han (+86 13858126927, 13858126927@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the rbcDNA blood test for gastric cancer screening (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 Aug 2026.