Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT02968069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2016-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2016-11-11', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.', 'detailedDescription': 'Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.Many studies have shown that there exist considerable discrepancies between EFB and subsequently resected specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be observed. Here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected of having a cancerous lesions\n* The age of patients is from 40-80 years\n* Patients must undergo esophagogastroduodenoscopy\n\nExclusion Criteria:\n\n* Clinical diagnosis of advanced gastric cancer\n* Acute upper gastrointestinal bleeding\n* Severe systemic diseases\n* Refuse to attend the study'}, 'identificationModule': {'nctId': 'NCT02968069', 'briefTitle': 'A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Development and Validation of a Predictive Model for Early Gastric Cancerous Lesions Under Endoscopic Observation', 'orgStudyIdInfo': {'id': '2016-138k'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suspected gastric cancerous lesions', 'description': 'Magnifying endoscopy with NBI would be conducted for every patient included in our study', 'interventionNames': ['Device: NBI']}], 'interventions': [{'name': 'NBI', 'type': 'DEVICE', 'otherNames': ['Evis Lucera system (CV-260, Olympus Inc, Japan)', 'high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan)', 'magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)'], 'description': 'Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.', 'armGroupLabels': ['Suspected gastric cancerous lesions']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiaobo Li, MD.Ph.D', 'role': 'CONTACT', 'email': 'lxb_1969@163.com', 'phone': '86-21-58752345'}], 'overallOfficials': [{'name': 'Xiaobo Li, MD.Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Putuo District Center Hospital', 'class': 'OTHER'}, {'name': 'Shanghai MCC worker hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaobo Li', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}