Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 9:41 AM
Study NCT ID:
NCT04184960
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2019-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AG & IM in CA Stomach Protocol
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: