AG & IM in CA Stomach Protocol

NCT ID: NCT04184960

Last Updated: 2023-09-07

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

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-05

Study Completion Date

2024-03-31

Brief Summary

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This is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development.

Detailed Description

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The case control study would compare which type of assessment (Endoscopic / histological) is more accurate in predicting the risk of gastric cancer development.

The risk factor assessment would be based on the following criteria.

Endoscopic assessment:

1. Atrophic gastritis, based on Kimura Takemoto Classification
2. Kyoto classification of gastritis
3. Intestinal metaplasia, based on Endoscopic Mapping and Grading of Intestinal Metaplasia (EGGIM) Histological assessment (Based on random biopsies)

1\. Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia

Conditions

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Gastric Cancer Atrophic Gastritis Intestinal Metaplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric cancer cohort

Cohort of patients with gastric cancer

Gastroscopy and gastric biopsies

Intervention Type DIAGNOSTIC_TEST

Gastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM

Non-gastric cancer cohort

Cohort of patients without gastric cancer

Gastroscopy and gastric biopsies

Intervention Type DIAGNOSTIC_TEST

Gastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM

Interventions

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Gastroscopy and gastric biopsies

Gastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age 40 or above
2. Undergo elective upper gastrointestinal endoscopy

Exclusion Criteria

1. Patients with history of gastrectomy
2. Patients with severe thrombocytopenia (Platelet count \<50) or coagulopathy (INR \> 1.5 or on anticoagulation)
3. Contraindication to upper gastrointestinal endoscopy
4. Allergy towards sedative agents (Midazolam / Diazepam) or local anaesthetic spray (Lignocaine)
5. Patients who cannot give informed consent
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Hon Chi Yip

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hon Chi Yip

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Osaka International Cancer Institute

Osaka, , Japan

Site Status NOT_YET_RECRUITING

Changi General Hospital

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

King Chulalongkorn Memorial Hospital and Chulalongkorn University

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Countries

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Hong Kong Japan Singapore Thailand

Central Contacts

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Hon Chi Yip, FRCSEd(Gen)

Role: CONTACT

+852 35052627

Facility Contacts

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Hon Chi Yip, FRCSEd (Gen)

Role: primary

+852 35052627

Noriya Uedo

Role: primary

James Weiquan Li

Role: primary

Rapat Pittayanon, MD, MSc

Role: primary

Other Identifiers

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CRE-2019.341

Identifier Type: -

Identifier Source: org_study_id

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