Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-28 @ 6:39 AM
Study NCT ID:
NCT04331951
Status:
UNKNOWN
Last Update Posted:
2021-04-06
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The pathologists will be blinded for the result of endoscopic finding'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2020-03-31', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis', 'timeFrame': '4 weeks after completing the enrollment.', 'description': 'Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intestinal Metaplasia']}, 'descriptionModule': {'briefSummary': "Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis\n\nObjective:\n\nThe aim of this study is to evaluate the sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis\n\nResearch design: Diagnosis study\n\nSample size: 105 cases\n\nData analysis:\n\nThe outcomes will be presented using 2 by 2 tables and if the data are normal distribution the categorical data will be analysed using McNemar's test", 'detailedDescription': 'Background and Rationale:\n\nGastric cancer has been in the top-5 of cancer-related death worldwide. Early detection by screening program in high risk patients is very important. If we can detect pre-malignant lesion eg. gastric intestinal metaplasia, we can provide the appropriate surveillance program to those patients. However, the screening protocol for gastric intestinal metaplasia remained unclear. Recently in July 2019, British Society of Gastroenterology published the guideline on the diagnosis and management of patients at risk of gastric adenocarcinoma. The image-enhanced endoscopy (IEE) is recommended as the best modality for assessing gastric intestinal metaplasia. Additionally, they recommended taking biopsy by using Sydney protocol which means taking biopsy at two areas for antrum, two areas for body and one for incisura although they look normal. We aimed to evaluate the sensitivity of this protocol for extensive gastric intestinal metaplasia (GIM) diagnosis in this study.\n\nMethodology:\n\n* All patients with history of GIM will be enrolled and undergone standard with white light esophagogastroduodenoscopy (EGD).\n* Those with suspected lesions of GIM will proceed to narrow band imaging (NBI)-mode endoscopy.\n* Targeted biopsy will be done at the suspected GIM lesions. Random biopsy will be while will be done if no suspicious GIM lesion seen.\n\nData collection:\n\nAll data will be processed and recorded by one physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 year of age\n* Suspected GIM by previous tissue pathology\n* Able to provide informed consent for participation\n\nExclusion Criteria:\n\n* Previous gastric surgery including gastrectomy and bypass surgery\n* Coagulopathy\n* Pregnancy\n* Active upper GI bleeding'}, 'identificationModule': {'nctId': 'NCT04331951', 'briefTitle': 'Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM', 'organization': {'class': 'OTHER', 'fullName': 'King Chulalongkorn Memorial Hospital'}, 'officialTitle': 'Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis', 'orgStudyIdInfo': {'id': 'RP016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Targeted biopsy within Sydney Protocol', 'description': 'The patients with history of gastric intestinal metaplasia will be included and using targeted biopsy within Sydney Protocol; both targeted biopsy at suspicious lesions and random biopsy at no suspicious area.\n\n* All tissues will be sent to immunohistochemistry as a gold standard.\n* Sensitivity, specificity,positive predictive value, negative predictive value, accuracy will be calculated.', 'interventionNames': ['Diagnostic Test: Targeted biopsy within Sydney protocol']}], 'interventions': [{'name': 'Targeted biopsy within Sydney protocol', 'type': 'DIAGNOSTIC_TEST', 'description': 'Biopsy at suspicious GIM lesions at any area of antrum (both lesser and greater curvature site), body (both lesser and greater curvature site) and incisura. If there is no abnormal mucosa seen at any site, random biopsy will be performed.', 'armGroupLabels': ['Targeted biopsy within Sydney Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rapat Pittayanon, MD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'rapat125@gmail.com'}], 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Rapat Pittayanon, MD', 'role': 'CONTACT', 'email': 'rapat125@gmail.com', 'phone': '66804224999'}, {'name': 'Natee Faknak, MD', 'role': 'CONTACT', 'email': 'F.natee30@gmail.com', 'phone': '66872006828'}], 'overallOfficials': [{'name': 'Rapat Pittayanon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Chulalongkorn Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Chulalongkorn Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rapat Pittayanon', 'investigatorAffiliation': 'King Chulalongkorn Memorial Hospital'}}}}