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

NCT05447221 | Unknown

• 1 other identifier: 2022-SDU-QILU-110
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Intestinal Metaplasia; Artificial Intelligence; Pathology; Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The diagnostic performance of AI model to assess the severity of intestinal metaplasia

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

  2 years

Secondary Outcomes (2)

• Accuracy of the digital pathological AI model to identify tumor regions

  2 years

• Accuracy of digital pathological AI models to identify glands, mucosal epithelium, and intestinal metaplasia in non-neoplastic areas

  2 years

Study Arms (1)

Whole slide images of gastric biopsy specimens

Whole slide images of gastric biopsy specimens

Diagnostic Test: The diagnosis of Artificial Intelligence and pathologists

Interventions

The diagnosis of Artificial Intelligence and pathologists DIAGNOSTIC_TEST

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.

Whole slide images of gastric biopsy specimens

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies from the gastric antrum and body will be prospectively collected and prepared as whole slide images for histology examination and model validation.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yanqing Li, MD, PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Yanqing Li, MD, PhD

CONTACT

0531182169385; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Qilu Hospital

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 7, 2022
• Study Start: August 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

CN (1)