Digestive OncologyNCT07274579
An Artificial Intelligence Model for Aiding Claudin18.2 Expression Diagnosis in Gastric Adenocarcinoma
An observational study of Digestive Oncology, run by Nanfang Hospital, Southern Medical University at 2 sites in China.
Trial summary
The investigators plan to develop a deep learning-based automatic interpretation model for Claudin18.2(CLDN18.2) using the institution's and multiple other centers' extensive pathological resources of digestive system adenocarcinomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Oncology
- How many people
- 2,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2025to Aug 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion criteria comprised patients aged over 18 years with definitive pathological diagnoses.
Who may be able to join
- Age over 18 years.
- Patients who underwent CLDN18.2 immunohistochemistry and H\&E staining.
- Availability of complete pathology reports and clinical information.
Who cannot join
- 1.Patients with missing data or specimens not meeting quality control requirements for analysis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Qianfoshan Hospital
Jinan, Shandong, 250014
About this study
Official title: Development and Real-World Validation of an Intelligent Interpretation Model for Claudin18.2 Protein Expression in Digestive System Tumors
The investigators plan to develop a deep learning-based automatic interpretation model for Claudin18.2(CLDN18.2) using the institution's and multiple other centers' extensive pathological resources of digestive system adenocarcinomas. This study will not only strictly follow the latest domestic expert consensus and standards, but also aims to address current pain points in manual interpretation. It seeks to provide technical support for standardizing, objectifying, and streamlining CLDN18.2 testing, thereby advancing the application of precision medicine in the diagnosis and treatment of digestive system diseases. The project has clear clinical necessity and broad application prospects.
- Conditions
- Digestive Oncology
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 |
|---|---|---|
| Prospective validation dataset | We conducted a prospective validation study to compare the diagnostic performance among pathologists, our pathology foundation model, and pathologist-with-AI-assisted diagnosis. This study was initiated on October 1, 2025 at Nanfang Hospital, Southern Medical University (NFHSMU) | |
| QFSH external validation dataset | 2000 slides from 1000 eligible individuals were obtained in the Qianfoshan Hospital (QFSH, Jinan, China) between January 2020 and February 2026, which was used to validate the model. | |
| Randomized controlled trial | We conducted a randomized controlled trial（RCT）to compare the diagnostic performance among pathologists, the pathology foundation model, and pathologist-with-model-assisted diagnosis at Nanfang Hospital of Southern Medical University (NFHSMU).The trial commenced data collection on February 1, 2023 to establish the NFHSMU randomized controlled trial dataset. Following quality control, the slides were randomly allocated (1:1 ratio) into three groups:Pathologist-only group/Model-assisted pathologist group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under ROC curve (AUC)
Area under the curve
Measured: Diagnostic evaluation will be performed within 1 week when the whole slide images(WSIs) are obtained.
Secondary outcomes (2)
Specificity
The true negative rate (TNR) of the diagnostic platform, which is the ratio between the number of negative individuals correctly categorized by platform and the total number of actual negative individuals (%).
Measured: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained
Sensitivity
The true positive rate (TPR) of the diagnostic platform, which is the ratio between the number of positive individuals correctly categorized by platform and the total number of actual positive individuals (%).
Measured: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Oct 2025
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive OncologyStudies of the same condition, open and under way.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital
- Responsible party
- Sponsor
- Investigators
- Li Liang, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274579
- Sponsor's protocol ID
- NFEC-2025-619
- Status last verified
- Feb 2026
- First submitted
- 27 Nov 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Individual data sharing
- No: Requests for the data collected and analyzed in this study will be considered if the application is in line with public benefits and the applicant is willing to sign a data access agreement. Contact can be through the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Real-World Validation of an Intelligent Interpretation Model for Claudin18.2 Protein Expression in Digestive System Tumors
- ClinicalTrials.gov ID
- NCT07274579
- Acronym / sponsor ID
- NFEC-2025-619
- Conditions
- Digestive Oncology
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 10 Dec 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.
The investigators plan to develop a deep learning-based automatic interpretation model for Claudin18.2(CLDN18.2) using the institution's and multiple other centers' extensive pathological resources of digestive system adenocarcinomas. This study will not only strictly follow the latest domestic expert consensus and standards, but also aims to address current pain points in manual interpretation. It seeks to provide technical support for standardizing, objectifying, and streamlining CLDN18.2 testing, thereby advancing the application of precision medicine in the diagnosis and treatment of digestive system diseases. The project has clear clinical necessity and broad application prospects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective validation dataset | – | –We conducted a prospective validation study to compare the diagnostic performance among pathologists, our pathology foundation model, and pathologist-with-AI-assisted diagnosis. This study was initiated on October 1, 2025 at Nanfang Hospital, Southern Medical University (NFHSMU) |
| QFSH external validation dataset | – | –2000 slides from 1000 eligible individuals were obtained in the Qianfoshan Hospital (QFSH, Jinan, China) between January 2020 and February 2026, which was used to validate the model. |
| Randomized controlled trial | – | –We conducted a randomized controlled trial（RCT）to compare the diagnostic performance among pathologists, the pathology foundation model, and pathologist-with-model-assisted diagnosis at Nanfang Hospital of Southern Medical University (NFHSMU).The trial commenced data collection on February 1, 2023 to establish the NFHSMU randomized controlled trial dataset. Following quality control, the slides were randomly allocated (1:1 ratio) into three groups:Pathologist-only group/Model-assisted pathologist group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria comprised patients aged over 18 years with definitive pathological diagnoses.
Key inclusion criteria (3 listed)
- Age over 18 years.
- Patients who underwent CLDN18.2 immunohistochemistry and H\&E staining.
- Availability of complete pathology reports and clinical information.
Key exclusion criteria (1 listed)
- 1.Patients with missing data or specimens not meeting quality control requirements for analysis.
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
Area under ROC curve (AUC)
Time frame: Diagnostic evaluation will be performed within 1 week when the whole slide images(WSIs) are obtained.
Area under the curve
2 secondary outcomes
Specificity
Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained
Sensitivity
Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained
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 10 Feb 2026.
- Individual participant dataSharing planned: No. Requests for the data collected and analyzed in this study will be considered if the application is in line with public benefits and the applicant is willing to sign a data access agreement. Contact can be through the corresponding author.
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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.
Li Liang study director
Nanfang Hospital, Southern Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive Oncology, run by Nanfang Hospital, Southern Medical University at 2 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 10 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 2 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?
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?
Area under ROC curve (AUC) (time frame: Diagnostic evaluation will be performed within 1 week when the whole slide images(WSIs) are obtained.). 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 10 Feb 2026.