NCT05447221

Automatic Evaluation of the Severity of Gastric Intestinal Metaplasia With Pathology Artificial Intelligence Diagnosis System

Automatic Evaluation of the Severity of Gastric Intestinal Metaplasia With Pathology Artificial Intelligence Diagnosis System: a Diagnostic Test

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The OLGIM staging system is highly recommended for a comprehensive assessment of GIM severity to evaluate patients' gastric cancer risk. However, its need to take at least 4 biopsies is not clinically feasible due to a serious shortage of pathologists compared with the large number of gastric cancer screening population. We plan to develop a Digital Pathology artificial intelligence diagnosis system (DPAIDS), to automatically identify tumor areas in whole slide images(WSI) and quickly and accurately quantify the severity of intestinal metaplasia according to the proportion of intestinal metaplasia areas.

Detailed description

Gastric cancer is the fifth most prevalent malignancy and the third most deadly worldwide, and intestinal metaplasia (IM) is a common precancerous state that is closely associated with gastric carcinogenesis .The OLGIM staging system is highly recommended for a comprehensive assessment of GIM severity to evaluate patients' gastric cancer risk. However, its need to take at least four biopsies is not clinically feasible due to a serious shortage of pathologists compared with the large number of gastric cancer screening population. Developing automated screening methods can reduce the heavy diagnostic workload. With advances in digital pathology scanning devices and deep learning technologies, whole-slide images (WSI) have been used to develop automated cancer diagnostic systems. We plan to develop a Digital Pathology artificial intelligence diagnosis system (DPAIDS), to automatically identify tumor areas in whole slide images(WSI) and quickly and accurately quantify the severity of intestinal metaplasia according to the proportion of intestinal metaplasia areas. Then biopsies will be prospectively collected and prepared as WSI for model validation.

Conditions

• Gastric Intestinal Metaplasia
• Artificial Intelligence
• Pathology
• Gastric Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The diagnosis of Artificial Intelligence and pathologists	Pathologists and AI will assess the severity of intestinal metaplasia and judge the tumor area of whole slide images of gastric biopsy specimens independently. In addition, the pathologists can not see the diagnosis of AI.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-07-07
• Last updated: 2023-09-06

Locations

1 site across 1 country: China