AG & IM in CA Stomach Protocol

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    400
  • sponsor
    Chinese University of Hong Kong
Updated on 24 March 2022
endoscopy
gastroscopy
Accepts healthy volunteers

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)
  4. Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia

Details
Condition Gastric Cancer, Atrophic Gastritis, Intestinal Metaplasia
Treatment Gastroscopy and gastric biopsies
Clinical Study IdentifierNCT04184960
SponsorChinese University of Hong Kong
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 40 or above
Undergo elective upper gastrointestinal endoscopy

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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