Early Gastric Cancer, Gastric Adenocarcinoma
Conditions
Brief summary
To estimate the prevalence of histologically confirmed early gastric cancer (EGC) in an Indian multicentre cohort undergoing standardised 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.
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 and South Korea. In contrast, most patients in India are diagnosed at advanced stages, resulting in poor outcomes. The Correa cascade 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. The Observational Study Model is recorded as 'Other' because IND-PREP is a single-time-point, cross-sectional diagnostic study and does not conform to the listed epidemiologic models (cohort, case-control, case-only, case-crossover, ecologic, or family-based). A defined group of patients undergoing upper gastrointestinal endoscopy is assessed at one point for the detection and characterisation of early gastric cancer and precancerous conditions. There is no longitudinal follow-up and no exposure-defined comparison group, consistent with the Cross-Sectional time perspective.
Interventions
None listed
Sponsors
Asian Institute of Gastroenterology, India
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults aged ≥40 years undergoing upper gastrointestinal endoscopy for dyspepsia or other clinical indications (nonalarming and alarming symptoms both). 2. Ability to provide written informed consent.
Exclusion criteria
1. Known gastric malignancy. 2. Prior gastric surgery (excluding H. pylori eradication). 3. Contraindications to endoscopy or biopsy. 4. Known hereditary gastric cancer syndromes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of histologically confirmed early gastric cancer | 2 years | Prevalence (proportion) of histologically confirmed early gastric cancer (EGC) detected on biopsy or endoscopic resection specimen during the endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of gastric precancerous lesions | 2 years | Prevalence and distribution of gastric precancerous lesions, including: Atrophic gastritis, Intestinal metaplasia (EGGIM positive: Yes/No; and histologic IM/OLGIM), Low-grade dysplasia (LGD), High-grade dysplasia (HGD), Advanced precancerous phenotype (OLGIM III-IV and/or HGD) |
| Clinical and demographic predictors | 2 years | Predictors of precancerous lesions |
| Endoscopy-pathology concordance | 2 years | Endoscopy-pathology concordance, including concordance between: Endoscopic suspicion and histology |
Countries
India
Contacts
CONTACTDr.Hardik Rughwani Dr.Hardik Rughwani, MBBS, MD, DM
Outcome results
None listed