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NCT Number: NCT07486518

A Multicentre Observational Cross-Sectional Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Adults aged ≥40 years undergoing upper gastrointestinal endoscopy for dyspepsia or other clinical indications (nonalarming and alarming symptoms both).
  • Ability to provide written informed consent.

Exclusion criteria

  • Known gastric malignancy.
  • Prior gastric surgery (excluding H. pylori eradication).
  • Contraindications to endoscopy or biopsy.
  • Known hereditary gastric cancer syndromes.

Treatment and study plan

Primary outcomes

  1. Prevalence of histologically confirmed early gastric cancer

    Time frame: 2 years

    Prevalence (proportion) of histologically confirmed early gastric cancer (EGC) detected on biopsy or endoscopic resection specimen during the endoscopy.

Secondary outcomes

  1. Prevalence of gastric precancerous lesions

    Time frame: 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)

  2. Clinical and demographic predictors

    Time frame: 2 years

    Predictors of precancerous lesions

  3. Endoscopy-pathology concordance

    Time frame: 2 years

    Endoscopy-pathology concordance, including concordance between: Endoscopic suspicion and histology

Study contacts

Contact information is provided by the study sponsor or research team.

Dr.Hardik Rughwani Dr.Hardik Rughwani, MBBS, MD, DM

CONTACT

[email protected]

+91-9426928600

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Acronym: IND-PREP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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