Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:02 PM
Study NCT ID:
NCT07486518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicentre Prospective Cohort Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of histologically confirmed early gastric cancer', 'timeFrame': '2 years', 'description': 'Prevalence (proportion) of histologically confirmed early gastric cancer (EGC) detected on biopsy or endoscopic resection specimen during the endoscopy.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of gastric precancerous lesions', 'timeFrame': '2 years', 'description': 'Prevalence and distribution of gastric precancerous lesions, including:\n\nAtrophic 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)'}, {'measure': 'Clinical and demographic predictors', 'timeFrame': '2 years', 'description': 'Predictors of precancerous lesions'}, {'measure': 'Endoscopy-pathology concordance', 'timeFrame': '2 years', 'description': 'Endoscopy-pathology concordance, including concordance between: Endoscopic suspicion and histology'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Adenocarcinoma', 'Early Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'To estimate the prevalence of histologically confirmed early gastric cancer (EGC) in an Indian multicentre cohort undergoing standardized high-quality upper gastrointestinal endoscopy.\n\nEGC is defined as gastric adenocarcinoma confined to the mucosa or submucosa (T1), irrespective of lymph node status, based on histopathology.', 'detailedDescription': '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 (1) and South Korea (2). In contrast, most patients in India are diagnosed at advanced stages, resulting in poor outcomes. The Correa cascade (3) (4) 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.\n\nIndia 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '4,000', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Adults aged ≥40 years undergoing upper gastrointestinal endoscopy for dyspepsia or other clinical indications (nonalarming and alarming symptoms both).\n2. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Known gastric malignancy.\n2. Prior gastric surgery (excluding H. pylori eradication).\n3. Contraindications to endoscopy or biopsy.\n4. Known hereditary gastric cancer syndromes.'}, 'identificationModule': {'nctId': 'NCT07486518', 'acronym': 'IND-PREP', 'briefTitle': 'A Multicentre Prospective Cohort Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'A Multicentre Prospective Cohort Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India', 'orgStudyIdInfo': {'id': 'IND-PREP-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '500032', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'contacts': [{'name': 'Sana Fathima Facility Contact', 'role': 'CONTACT', 'email': 'aigresearch7@gmail.com', 'phone': '9182859523'}], 'facility': 'AIG Hospitals', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'centralContacts': [{'name': 'Dr.Hardik Rughwani Dr.Hardik Rughwani, MBBS, MD, DM', 'role': 'CONTACT', 'email': 'hardik.hr@gmail.com', 'phone': '+91-9426928600'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Interventional Endoscopy', 'investigatorFullName': 'Mohan Ramchandani', 'investigatorAffiliation': 'Asian Institute of Gastroenterology, India'}}}}