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Clinical Trial Summary

The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the extent of esophageal cancer invasion than what is currently possible with ultrasound technology. This research endeavors to harness the synergy of endoscopic ultrasound (EUS) and Magnifying endoscopy, augmented by the pattern recognition and correlation capabilities of artificial intelligence (AI), to detect early esophageal squamous cell carcinoma and its invasiveness, along with high-grade intraepithelial neoplasia. The overarching goal is to ascertain the potential and significance of this approach in the early detection of esophageal cancer. The project's primary goals are to develop three distinct AI-assisted diagnostic systems: An AI-driven electronic endoscopic diagnosis system designed to autonomously identify lesions. An AI-based EUS diagnostic system capable of automatically delineating the affected areas. A multimodal diagnostic framework that integrates electronic endoscopy with EUS to enhance diagnostic accuracy and efficiency.


Clinical Trial Description

The study was executed in two distinct phases. The initial phase, designated as the modeling phase (Phase 1), involved a retrospective analysis of eligible subjects from a consortium of medical institutions, including the First Affiliated Hospital of Naval Medical University, West China Hospital of Sichuan University, Provincial Hospital Affiliated to Shandong First Medical University, the First Affiliated Hospital of Soochow University, the First Affiliated Hospital of Henan University of Science and Technology, and the First Affiliated Hospital of Shihezi University, all selected prior to January 1, 2024. The second phase, known as the real-world evaluation phase (Phase 2), prospectively enrolled consecutive patients who were scheduled to undergo magnometric endoscopy and EUS at the aforementioned hospitals between April 2024 and June 2024. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06412419
Study type Observational
Source Changhai Hospital
Contact Luowei Wang
Phone 86-21-31161337
Email wangluoweimd@smmu.edu.cn
Status Not yet recruiting
Phase
Start date May 15, 2024
Completion date October 30, 2024

See also
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Completed NCT06381583 - A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma