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RecruitingNCT04184960Updated Sep 7, 2023

AG & IM in CA Stomach Protocol

An observational study in Gastric Cancer, Atrophic Gastritis and Intestinal Metaplasia, sponsored by Chinese University of Hong Kong. Recruiting at 4 sites in 4 countries. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Started Dec 2019; still recruiting 6 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
40 Years and older
Sex
All
01

Study summary

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.

Read the 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
02

Conditions studied

  • Gastric Cancer
  • Atrophic Gastritis
  • Intestinal Metaplasia

Keywords

  • Gastric cancer
  • Gastroscopy
  • Atrophic gastritis
  • Intestinal metaplasia
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 400 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
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.

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

Inclusion criteria:

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Gastric cancer cohort

    Cohort of patients with gastric cancer

    Diagnostic Test: Gastroscopy and gastric biopsies

  • Non-gastric cancer cohort

    Cohort of patients without gastric cancer

    Diagnostic Test: Gastroscopy and gastric biopsies

Interventions

  • Diagnostic testGastroscopy 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

06

What researchers measure

Primary outcomes

  1. Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)

    Endoscopic description of severity of gastric atrophy

    Time frame: Cross sectional study, day 0

  2. Endoscopic grading of intestinal metaplasia (EGGIM)

    Endoscopic mapping of degree of intestinal metaplasia

    Time frame: Cross sectional study, day 0

  3. Kyoto classification of gastritis

    Descriptive findings of gastritis

    Time frame: Cross sectional study, day 0

  4. Operative links on gastritis assessment (OLGA)

    Biopsy based risk stratification panel based on severity of atrophic gastritis

    Time frame: Cross sectional study, day 0

  5. Operative links on gastric intestinal metaplasia (OLGIM)

    Biopsy based risk stratification panel based on severity of intestinal metaplasia

    Time frame: Cross sectional study, day 0

07

Study locations

1 of 4 sites recruiting
  • Prince of Wales Hospital
    Hong Kong, Hong Kong
    Recruiting
  • Osaka International Cancer Institute
    Osaka, Japan
    Not yet recruiting
  • Changi General Hospital
    Singapore, Singapore
    Not yet recruiting
  • King Chulalongkorn Memorial Hospital and Chulalongkorn University
    Bangkok, Thailand
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04184960
Lead sponsor
Chinese University of Hong Kong
Responsible party
Hon Chi Yip (Associate Consultant, Chinese University of Hong Kong) — Principal investigator
First posted
Dec 4, 2019
Start date
Dec 5, 2019
Primary completion
Jan 31, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Sep 7, 2023

Study contacts

Hon Chi Yip, FRCSEd(Gen)
Contact
hcyip@surgery.cuhk.edu.hk
+852 35052627
Hon Chi Yip
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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