Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-11 @ 8:24 PM
Study NCT ID:
NCT04184960
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2019-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AG & IM in CA Stomach Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D005757', 'term': 'Gastritis, Atrophic'}], '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'}, {'id': 'D005756', 'term': 'Gastritis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005773', 'term': 'Gastroscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '4 random biopsies would be taken in specific location of the stomach during gastroscopy. (Lesser curvature mid antrum, greater curvature mid antrum, lesser curvature mid corpus, greater curvature mid corpus)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2019-12-01', 'studyFirstSubmitQcDate': '2019-12-01', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)', 'timeFrame': 'Cross sectional study, day 0', 'description': 'Endoscopic description of severity of gastric atrophy'}, {'measure': 'Endoscopic grading of intestinal metaplasia (EGGIM)', 'timeFrame': 'Cross sectional study, day 0', 'description': 'Endoscopic mapping of degree of intestinal metaplasia'}, {'measure': 'Kyoto classification of gastritis', 'timeFrame': 'Cross sectional study, day 0', 'description': 'Descriptive findings of gastritis'}, {'measure': 'Operative links on gastritis assessment (OLGA)', 'timeFrame': 'Cross sectional study, day 0', 'description': 'Biopsy based risk stratification panel based on severity of atrophic gastritis'}, {'measure': 'Operative links on gastric intestinal metaplasia (OLGIM)', 'timeFrame': 'Cross sectional study, day 0', 'description': 'Biopsy based risk stratification panel based on severity of intestinal metaplasia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric cancer', 'Gastroscopy', 'Atrophic gastritis', 'Intestinal metaplasia'], 'conditions': ['Gastric Cancer', 'Atrophic Gastritis', 'Intestinal Metaplasia']}, 'descriptionModule': {'briefSummary': 'This is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development.', 'detailedDescription': 'The case control study would compare which type of assessment (Endoscopic / histological) is more accurate in predicting the risk of gastric cancer development.\n\nThe risk factor assessment would be based on the following criteria.\n\nEndoscopic assessment:\n\n1. Atrophic gastritis, based on Kimura Takemoto Classification\n2. Kyoto classification of gastritis\n3. Intestinal metaplasia, based on Endoscopic Mapping and Grading of Intestinal Metaplasia (EGGIM) Histological assessment (Based on random biopsies)\n\n1\\. Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with or without gastric cancer undergoing elective endoscopy would be recruited if they fulfil inclusion and exclusion criteria. Subsequently they would be analysed based on "Gastric cancer" and "Non-gastric cancer" cohorts.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Two groups of patients would be recruited in this case control study.\n\n1. Gastric neoplasia group Patients with newly diagnosed or history of cancer of stomach or gastric high grade dysplasia.\n2. Control group Patients with no prior history of gastric dysplasia or cancer\n\nInclusion criteria:\n\n1. Age 40 or above\n2. Undergo elective upper gastrointestinal endoscopy\n\nExclusion criteria:\n\n1. Patients with history of gastrectomy\n2. Patients with severe thrombocytopenia (Platelet count \\<50) or coagulopathy (INR \\> 1.5 or on anticoagulation)\n3. Contraindication to upper gastrointestinal endoscopy\n4. Allergy towards sedative agents (Midazolam / Diazepam) or local anaesthetic spray (Lignocaine)\n5. Patients who cannot give informed consent'}, 'identificationModule': {'nctId': 'NCT04184960', 'briefTitle': 'AG & IM in CA Stomach Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Performance of Endoscopic and Histological Criteria of Atrophic Gastritis and Intestinal Metaplasia in Predicting Risk of Gastric Cancer - a Multicenter Case Control Study', 'orgStudyIdInfo': {'id': 'CRE-2019.341'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric cancer cohort', 'description': 'Cohort of patients with gastric cancer', 'interventionNames': ['Diagnostic Test: Gastroscopy and gastric biopsies']}, {'label': 'Non-gastric cancer cohort', 'description': 'Cohort of patients without gastric cancer', 'interventionNames': ['Diagnostic Test: Gastroscopy and gastric biopsies']}], 'interventions': [{'name': 'Gastroscopy and gastric biopsies', 'type': 'DIAGNOSTIC_TEST', 'description': 'Gastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM', 'armGroupLabels': ['Gastric cancer cohort', 'Non-gastric cancer cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Hon Chi Yip, FRCSEd (Gen)', 'role': 'CONTACT', 'email': 'hcyip@surgery.cuhk.edu.hk', 'phone': '+852 35052627'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Osaka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Noriya Uedo', 'role': 'CONTACT', 'email': 'noriya.uedo@gmail.com'}], 'facility': 'Osaka International Cancer Institute', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'James Weiquan Li', 'role': 'CONTACT', 'email': 'james.li.w.q@singhealth.com.sg'}], 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Bangkok', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rapat Pittayanon, MD, MSc', 'role': 'CONTACT', 'email': 'rapat125@gmail.com'}], 'facility': 'King Chulalongkorn Memorial Hospital and Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Hon Chi Yip, FRCSEd(Gen)', 'role': 'CONTACT', 'email': 'hcyip@surgery.cuhk.edu.hk', 'phone': '+852 35052627'}], 'overallOfficials': [{'name': 'Hon Chi Yip', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Consultant', 'investigatorFullName': 'Hon Chi Yip', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}