AG & IM in CA Stomach Protocol

September 6, 2023 updated by: Hon Chi Yip, Chinese University of Hong Kong

Performance of Endoscopic and Histological Criteria of Atrophic Gastritis and Intestinal Metaplasia in Predicting Risk of Gastric Cancer - a Multicenter Case Control Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with or without gastric cancer undergoing elective endoscopy would be recruited if they fulfil inclusion and exclusion criteria. Subsequently they would be analysed based on "Gastric cancer" and "Non-gastric cancer" cohorts.

Description

Two groups of patients would be recruited in this case control study.

  1. Gastric neoplasia group Patients with newly diagnosed or history of cancer of stomach or gastric high grade dysplasia.
  2. Control group Patients with no prior history of gastric dysplasia or cancer

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric cancer cohort
Cohort of patients with gastric cancer
Diagnostic test: 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
Non-gastric cancer cohort
Cohort of patients without gastric cancer
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)
Time Frame: Cross sectional study, day 0
Endoscopic description of severity of gastric atrophy
Cross sectional study, day 0
Endoscopic grading of intestinal metaplasia (EGGIM)
Time Frame: Cross sectional study, day 0
Endoscopic mapping of degree of intestinal metaplasia
Cross sectional study, day 0
Kyoto classification of gastritis
Time Frame: Cross sectional study, day 0
Descriptive findings of gastritis
Cross sectional study, day 0
Operative links on gastritis assessment (OLGA)
Time Frame: Cross sectional study, day 0
Biopsy based risk stratification panel based on severity of atrophic gastritis
Cross sectional study, day 0
Operative links on gastric intestinal metaplasia (OLGIM)
Time Frame: Cross sectional study, day 0
Biopsy based risk stratification panel based on severity of intestinal metaplasia
Cross sectional study, day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Hon Chi Yip, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2019

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

December 1, 2019

First Submitted That Met QC Criteria

December 1, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2019.341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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