Clinical trial NCT04184960: AG & IM in CA Stomach Protocol
Official title: Performance of Endoscopic and Histological Criteria of Atrophic Gastritis and Intestinal Metaplasia in Predicting Risk of Gastric Cancer - a Multicenter Case Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Atrophic Gastritis
Intestinal Metaplasia
Keywords: Gastric cancer
Gastroscopy
Atrophic gastritis
Intestinal metaplasia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)
timeFrame: Cross sectional study, day 0
measure: Endoscopic grading of intestinal metaplasia (EGGIM)
timeFrame: Cross sectional study, day 0
measure: Kyoto classification of gastritis
timeFrame: Cross sectional study, day 0
measure: Operative links on gastritis assessment (OLGA)
timeFrame: Cross sectional study, day 0
measure: Operative links on gastric intestinal metaplasia (OLGIM)
timeFrame: Cross sectional study, day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital and Chulalongkorn University
Study officials:
affiliation: Chinese University of Hong Kong
name: Hon Chi Yip
role: PRINCIPAL_INVESTIGATOR
References: