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Enrolling by Invitation

NCT Number: NCT07274579

An Artificial Intelligence Model for Aiding Claudin18.2 Expression Diagnosis in Gastric Adenocarcinoma

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.

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Key information

Conditions

Digestive Oncology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Specificity

    Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

    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 (%).

  2. Sensitivity

    Time frame: Diagnostic evaluation will be performed within 1 week when the WSIs are obtained

    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 (%).

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Qianfoshan Hospital

Registry information

Official study title

Development and Real-World Validation of an Intelligent Interpretation Model for Claudin18.2 Protein Expression in Digestive System Tumors

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 10, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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