JMIR Publications

ABSTRACT

Background:

Gastric cancer remains a leading cause of cancer-related mortality globally, and most patients in India are diagnosed at advanced stages. The Correa cascade describes stepwise progression from chronic gastritis through atrophic gastritis, intestinal metaplasia (IM), and dysplasia to adenocarcinoma, driven largely by Helicobacter pylori infection. India lacks high-quality multicentre data on the prevalence and spectrum of gastric precancerous lesions and early gastric cancer (EGC).

Objective:

The IND-PREP study aims to estimate the prevalence of histologically confirmed EGC and to systematically evaluate the gastric precancerous epithelial pathway using standardised high-definition endoscopy and histopathology across 15 tertiary referral centres in India.

Methods:

The IND-PREP study is a multicentre, observational cross-sectional study across 15 tertiary referral centres in India. Consecutive adults aged ≥40 years undergoing upper gastrointestinal endoscopy are enrolled. Endoscopies are performed on high-definition Olympus platforms (EVIS X1/1500CV) with white-light and narrow-band imaging by endoscopists trained under supervision from Japanese experts. Biopsies follow the updated Sydney protocol (five sites, three bottles) plus targeted biopsies of suspicious lesions. Histopathology follows a standardised multicentre framework with structured synoptic reporting, centralised training, trigger-based adjudication, and random audit. Participating endoscopists and pathologists underwent diagnostic calibration before enrolment. The primary outcome is the prevalence of histologically confirmed EGC. Secondary outcomes include the prevalence of gastric precancerous lesions, endoscopy–pathology concordance, diagnostic performance of EGGIM, and predictors of advanced-stage precancerous lesions (OLGIM III–IV and/or high-grade dysplasia). Approximately 4,000 participants will estimate EGC prevalence with ±0.3% precision at 95% confidence, accounting for clustering (design effect 1.3) and 10% attrition. Analyses will use generalised estimating equations or mixed-effects models to account for centre-level clustering. The study was approved by the Institutional Ethics Committee of the Asian Institute of Gastroenterology (AIG/IEC-BH&R 79/02.2026/01; amendment AIG/IEC-BH&R 79/02.2026-1/AMD/01).

Results:

The Asian Healthcare Foundation, Hyderabad, India, is funding the study. Recruitment commenced on 1 August 2026 across the 15 participating centres, and data collection is expected to be completed by 1 April 2028 (estimated). Results are expected to be submitted for publication in 2028.

Conclusions:

The IND-PREP study will provide the first large-scale multicentre estimate of the prevalence of EGC and gastric precancerous lesions in India, establish diagnostic benchmarks for endoscopic and histologic assessment, and inform the design of risk-stratified screening and surveillance strategies. We will disseminate findings through peer-reviewed publications and scientific meetings. Clinical Trial: ClinicalTrials.gov NCT07486518; https://clinicaltrials.gov/study/NCT07486518 (registered 18 March 2026).