AG & IM in CA Stomach Protocol

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04184960
• Other study ID #: CRE-2019.341
• Status: Recruiting
• Start date: December 5, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: Hon Chi Yip, FRCSEd(Gen)
• Phone: +852 35052627
• Email: hcyip[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Gastritis
• Atrophy
• Gastric Cancer
• Gastritis
• Gastritis, Atrophic
• Intestinal Metaplasia
• Metaplasia
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong
Japan	Osaka International Cancer Institute	Osaka
Singapore	Changi General Hospital	Singapore
Thailand	King Chulalongkorn Memorial Hospital and Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Countries where clinical trial is conducted

Hong Kong,  Japan,  Singapore,  Thailand, 

Outcome

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