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

Shandong University

Status: Enrolling

Conditions: Gastric Cancer; Artificial Intelligence; Gastric Intestinal Metaplasia; Pathology

Treatments: Diagnostic Test: The diagnosis of Artificial Intelligence and pathologists

Study type: Observational

Funder types: Other

Identifiers

NCT05447221

2022-SDU-QILU-110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged 40-75 years who undergo the gastroscopy examination and biopsy

Exclusion criteria

• patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
• patients with previous surgical procedures on the stomach
• patients with contraindications to biopsy
• patients who refuse to sign the informed consent form

Trial design

150 participants in 1 patient group

Whole slide images of gastric biopsy specimens

Description:

Whole slide images of gastric biopsy specimens

Treatment:

Diagnostic Test: The diagnosis of Artificial Intelligence and pathologists