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Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis

Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis - Application of Artificial Intelligence in Histology and Clinical Data

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04840056
Acronym
GIMA
Enrollment
1300
Registered
2021-04-09
Start date
2021-04-15
Completion date
2025-12-31
Last updated
2024-08-29

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

Conditions

Atrophic Gastritis, Gastric Cancer, Intestinal Metaplasia

Keywords

artificial intelligence

Brief summary

The primary objectives of this study are: * To identify clinical or histological factors associated with gastric cancer development in patients with IM and AG * To establish a machine learning algorithm for prediction of future gastric cancer risks and individual risk stratification in patient with IM and AG

Detailed description

This is a two-part retrospective study including a clinical data part and a pathology part. A training cohort will be developed from approximately 70% of included cases. It will be followed by a validation cohort with the remaining cases. Clinical data will be collected retrospectively using the Clinical Data Analysis and Reporting System (CDARS) and Clinical management System (CMS). A cluster-wide cohort (New Territories East Cluster, NTEC) consisting of patients with history of histologically-proven gastric IM and AG will be identified and included for subsequent analysis. The data collection period for the retrospective data will be 2000-2020. Histology slides will be retrieved retrospectively when available (within NTEC). Whole slide imaging technique will be utilized for the development of training and validation cohorts with machine learning algorithms in the pathology part.

Interventions

None listed

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Adults \>= 18 years of age * Histologically proven atrophic gastritis or intestinal metaplasia (at antrum and/or body and/or angular of stomach)

Exclusion criteria

\- none

Design outcomes

Primary

MeasureTime frameDescription
Gastric cancer and gastric dysplasia20 yearsThe primary endpoint is the incidence of gastric cancer (intestinal-type) and gastric dysplasia (low grade and high grade dysplasia).

Secondary

MeasureTime frameDescription
Sensitivity of machine learning model20 yearsSensitivity of machine learning model will be evaluated
Specificity of machine learning model20 yearsSpecificity of machine learning model will be evaluated
Overall accuracy of machine learning model20 yearsOverall accuracy of machine learning models will be evaluated
Negative predictive value of machine learning model20 yearsNegative predictive value of machine learning model will be evaluated
Area under the receiver operating characteristic curve of machine learning model20 yearsArea under the receiver operating characteristic curve of machine learning model will be evaluated
Positive predictive value of machine learning model20 yearsPositive predictive value of machine learning model will be evaluated

Countries

Hong Kong

Contacts

Primary ContactFelix Sia
felix.sia@cuhk.edu.hk+85226370428
Backup ContactThomas Lam
thomas.lam@cuhk.edu.hk+85226370428

Outcome results

None listed

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