Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis

NCT ID: NCT04840056

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Gastric Cancer Intestinal Metaplasia Atrophic Gastritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intestinal Metaplasia

patient with history of histologically proven gastric intestinal metaplasia

No interventions assigned to this group

Atrophic gastritis

patient with history of histologically proven atrophic gastritis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Louis Ho Shing Lau

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Felix Sia

Role: CONTACT

+85226370428

Thomas Lam

Role: CONTACT

+85226370428

Other Identifiers

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2021.082

Identifier Type: -

Identifier Source: org_study_id

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