NCT04184960

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 5, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

4.2 years

First QC Date

December 1, 2019

Last Update Submit

September 6, 2023

Conditions

Gastric CancerAtrophic GastritisIntestinal Metaplasia

Keywords

Gastric cancerGastroscopyAtrophic gastritisIntestinal metaplasia

Outcome Measures

Primary Outcomes (5)

  • Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)

    Endoscopic description of severity of gastric atrophy

    Cross sectional study, day 0

  • Endoscopic grading of intestinal metaplasia (EGGIM)

    Endoscopic mapping of degree of intestinal metaplasia

    Cross sectional study, day 0

  • Kyoto classification of gastritis

    Descriptive findings of gastritis

    Cross sectional study, day 0

  • Operative links on gastritis assessment (OLGA)

    Biopsy based risk stratification panel based on severity of atrophic gastritis

    Cross sectional study, day 0

  • Operative links on gastric intestinal metaplasia (OLGIM)

    Biopsy based risk stratification panel based on severity of intestinal metaplasia

    Cross sectional study, day 0

Study Arms (2)

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

Gastroscopy and gastric biopsiesDIAGNOSTIC_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

Gastric cancer cohortNon-gastric cancer cohort

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age 40 or above
  • Undergo elective upper gastrointestinal endoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Biospecimen

Retention: SAMPLES WITH DNA

4 random biopsies would be taken in specific location of the stomach during gastroscopy. (Lesser curvature mid antrum, greater curvature mid antrum, lesser curvature mid corpus, greater curvature mid corpus)

MeSH Terms

Conditions

Stomach NeoplasmsGastritis, Atrophic

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesGastritisGastroenteritis

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Hon Chi Yip

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Chi Yip, FRCSEd(Gen)

CONTACT

+852 35052627hcyip@surgery.cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

December 1, 2019

First Posted

December 4, 2019

Study Start

December 5, 2019

Primary Completion

January 31, 2024

Study Completion

March 31, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)TH(1)HK(1)SG(1)