Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:02 PM
Study NCT ID:
NCT07486518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicentre Prospective Cohort Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India
Sponsor:
Asian Institute of Gastroenterology, India
Organization:
Study Overview
Official Title:
A Multicentre Prospective Cohort Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
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:
IND-PREP
Brief Summary:
To estimate the prevalence of histologically confirmed early gastric cancer (EGC) in an Indian multicentre cohort undergoing standardized high-quality upper gastrointestinal endoscopy.
EGC is defined as gastric adenocarcinoma confined to the mucosa or submucosa (T1), irrespective of lymph node status, based on histopathology.
EGC is defined as gastric adenocarcinoma confined to the mucosa or submucosa (T1), irrespective of lymph node status, based on histopathology.
Detailed Description:
Gastric adenocarcinoma is a major global health problem and remains a leading cause of cancer-related mortality. Early detection significantly improves survival, with 5-year survival rates exceeding 80% in countries with established screening programmes, such as Japan (1) and South Korea (2). In contrast, most patients in India are diagnosed at advanced stages, resulting in poor outcomes. The Correa cascade (3) (4) describes a stepwise progression from chronic gastritis to atrophic gastritis, intestinal metaplasia (IM), dysplasia, and invasive adenocarcinoma. Helicobacter pylori infection is a major driver of this pathway. Identifying and characterising gastric precancerous lesions provides an opportunity for surveillance and early intervention.
India lacks high-quality multicentre data on the prevalence and spectrum of gastric precancerous lesions and early gastric cancer. This study aims to systematically evaluate the gastric precancerous epithelial pathway using high-definition endoscopy and standardised histopathology across multiple centres in India.
India lacks high-quality multicentre data on the prevalence and spectrum of gastric precancerous lesions and early gastric cancer. This study aims to systematically evaluate the gastric precancerous epithelial pathway using high-definition endoscopy and standardised histopathology across multiple centres in India.
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?: