NCT07551466Recruiting
AI Model for Early Gastric Cancer Diagnosis Using Endoscopic Imaging
Development and Validation of an Explainable Artificial Intelligence Model for Early Gastric Cancer Diagnosis Using Multimodal Endoscopic Imaging
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
Early gastric cancer (EGC) is often difficult to detect accurately during endoscopic examination due to subtle morphological features and variability among endoscopists. Artificial intelligence (AI) has shown promise in improving diagnostic performance; however, most existing models lack interpretability and rely on single-modality imaging. This study aims to develop and evaluate an explainable multimodal artificial intelligence model for the diagnosis of early gastric cancer using endoscopic imaging. The model integrates features derived from white-light imaging and image-enhanced endoscopy, along with quantitative image features and clinical data, to improve diagnostic accuracy and provide interpretable decision support. The primary outcome is the diagnostic performance of the AI model for detecting early gastric cancer, evaluated by area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity. The results of this study are expected to provide evidence for the clinical utility of explainable AI in endoscopic diagnosis and support the development of reliable human-AI collaborative diagnostic systems.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07551466
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 May 2026 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Non-adenocarcinoma histological types (e.g., lymphoma)
- Patients who did not undergo ME-NBI examination or did not receive ESD
- Lesions invading the muscularis propria or deeper layers
- Missing or indeterminate postoperative histopathological results
Who the study is looking for
- Age ≥18 years
- Suspicious gastric lesions identified on white-light imaging (WLI)
- Preoperative biopsy indicating precancerous lesions (dysplasia or intraepithelial neoplasia) or adenocarcinoma, with preoperative magnifying endoscopy with narrow-band imaging (ME-NBI) performed
- Patients meeting the absolute indications for endoscopic submucosal dissection (ESD) and who underwent ESD
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.