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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05447221
Enrollment
150
Registered
2022-07-07
Start date
2022-08-01
Completion date
2023-12-31
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Gastric Cancer, Gastric Intestinal Metaplasia, Pathology

Keywords

gastric cancer, Gastric Intestinal Metaplasia, Digital Pathology, Whole Slide Image

Brief 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.

Interventions

DIAGNOSTIC_TESTThe 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.

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The diagnostic performance of AI model to assess the severity of intestinal metaplasia2 yearsThe diagnostic performance of AI model to assess the severity of intestinal metaplasia in a single biopsy tissue slide: Accuracy, sensitivity, and specificity

Secondary

MeasureTime frameDescription
Accuracy of the digital pathological AI model to identify tumor regions2 yearsAccuracy of the digital pathological AI model in identifying tumor regions in the whole slide images
Accuracy of digital pathological AI models to identify glands, mucosal epithelium, and intestinal metaplasia in non-neoplastic areas2 yearsAccuracy of digital pathological AI models to identify glands, mucosal epithelium, and intestinal metaplasia in non-neoplastic areas

Countries

China

Contacts

Primary ContactYanqing Li, MD, PhD
liyanqing@sdu.edu.cn0531182169385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026