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

June 2, 2026 updated by: Mohan Ramchandani, Asian Institute of Gastroenterology, 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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr.Hardik Rughwani Dr.Hardik Rughwani, MBBS, MD, DM
  • Phone Number: +91-9426928600
  • Email: hardik.hr@gmail.com

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

4,000

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
Clinical and demographic predictors
Time Frame: 2 years
Predictors of precancerous lesions
2 years
Endoscopy-pathology concordance
Time Frame: 2 years
Endoscopy-pathology concordance, including concordance between: Endoscopic suspicion and histology
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND-PREP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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