Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-23 @ 4:30 AM
Study NCT ID:
NCT02516735
Status:
UNKNOWN
Last Update Posted:
2015-08-06
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-08-03', 'lastUpdatePostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of the detection rate of gastric intestinal metaplasia between i-scan with magnification targeted biopsies and standard endoscopy with standard biopsy protocol in a per-pateint analysis', 'timeFrame': 'seven months'}, {'measure': 'Difference of the detection rate of gastric intestinal metaplasia between i-scan with magnification targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis', 'timeFrame': 'seven months'}], 'secondaryOutcomes': [{'measure': 'Number of biopsies needed in per group', 'timeFrame': 'seven months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Intestinal Metaplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.', 'detailedDescription': 'Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. I-scan is a novel image-enhanced endoscopy system based on the post processing of reflected light without optical filters. Targeted biopsy protocol based on i-scan with magnification will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from i-scan with magnification targeted biopsies and a standard biopsy protocol and assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with dyspeptic symptoms and aged 40 years or older\n* or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis\n* or patients with family history of gastric cancer\n\nExclusion Criteria:\n\n* presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia\n* presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding\n* inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02516735', 'briefTitle': 'I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'I-scan With Magnification Targeted Biopsies Compared With a Standard Biopsy Protocol for the Detection of Gastric Intestinal Metaplasia in a High Risk Population: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2015SDU-QILU-G07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'I-scan with magnification targeted biopsies for gastric intestinal metapalsia.', 'interventionNames': ['Device: I-scan with magnification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Standard endoscopy with a standard biopsy protocol from the five standard biopsy sites following the updated Sydney System including two from the distal antrum (within 2-3cm from the pylorus, greater/lesser curvature), one from the incisura and two from the mid corpus (greater/lesser curvature).', 'interventionNames': ['Device: Standard endoscopy']}], 'interventions': [{'name': 'I-scan with magnification', 'type': 'DEVICE', 'armGroupLabels': ['Group 1']}, {'name': 'Standard endoscopy', 'type': 'DEVICE', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'CONTACT', 'email': 'qiluliyanqing@gmail.com', 'phone': '18678827666', 'phoneExt': '82169508'}], 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'CONTACT', 'email': 'qiluliyanqing@gmail.com', 'phone': '18678827666', 'phoneExt': '82169508'}], 'overallOfficials': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}