Gastric AdenocarcinomaIND-PREPNCT07486518
A Multicentre Observational Cross-Sectional Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India
An observational study of Gastric Adenocarcinoma and Early Gastric Cancer, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
To estimate the prevalence of histologically confirmed early gastric cancer (EGC) in an Indian multicentre cohort undergoing standardised high-quality upper gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Adenocarcinoma, Early Gastric Cancer
- How many people
- 4,000 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 4,000
Who may be able to join
None listed.
Who cannot join
- Known gastric malignancy.
- Prior gastric surgery (excluding H. pylori eradication).
- Contraindications to endoscopy or biopsy.
- Known hereditary gastric cancer syndromes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
AIG Hospitals
Hyderabad, Telangana, 500032
Sana Fathima Facility Contact, 9182859523, aigresearch7@gmail.com
About this study
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.
Read the 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.
- Conditions
- Gastric Adenocarcinoma, Early Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of histologically confirmed early gastric cancer
Prevalence (proportion) of histologically confirmed early gastric cancer (EGC) detected on biopsy or endoscopic resection specimen during the endoscopy.
Measured: 2 years
Secondary outcomes (3)
Prevalence of gastric precancerous lesions
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)
Measured: 2 years
Clinical and demographic predictors
Predictors of precancerous lesions
Measured: 2 years
Endoscopy-pathology concordance
Endoscopy-pathology concordance, including concordance between: Endoscopic suspicion and histology
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Aug 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486518
- Sponsor's protocol ID
- IND-PREP-01
- Acronym
- IND-PREP
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Observational Cross-Sectional Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India
- ClinicalTrials.gov ID
- NCT07486518
- Acronym / sponsor ID
- IND-PREP / IND-PREP-01
- Conditions
- Gastric Adenocarcinoma, Early Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 4,000
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Known gastric malignancy.
- Prior gastric surgery (excluding H. pylori eradication).
- Contraindications to endoscopy or biopsy.
- Known hereditary gastric cancer syndromes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Prevalence of gastric precancerous lesions
Time frame: 2 years
Clinical and demographic predictors
Time frame: 2 years
Endoscopy-pathology concordance
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Adenocarcinoma and Early Gastric Cancer, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr.Hardik Rughwani Dr.Hardik Rughwani, MBBS, MD, DM (+91-9426928600, hardik.hr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of histologically confirmed early gastric cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.