An Artificial Intelligence Model for Aiding Claudin18.2 Expression Diagnosis in Gastric Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Digestive Oncology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Real-World Validation of an Intelligent Interpretation Model for Claudin18.2 Protein Expression in Digestive System Tumors
Overview
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.
Primary outcome measures
- Area under ROC curve (AUC) [Time frame: Diagnostic evaluation will be performed within 1 week when the whole slide images(WSIs) are obtained.]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- Age over 18 years.
- Patients who underwent CLDN18.2 immunohistochemistry and H\&E staining.
- Availability of complete pathology reports and clinical information.
Exclusion criteria
1.Patients with missing data or specimens not meeting quality control requirements for analysis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Nanfang Hospital, Southern Medical University — Guangzhou
- Qianfoshan Hospital — Jinan
Identifiers
NCT: NCT07274579 · NFEC-2025-619