Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 12:40 PM
Study NCT ID:
NCT02932735
Status:
UNKNOWN
Last Update Posted:
2016-10-13
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Probe-based Confocal Laser Endomicroscopy in Staging OLGIM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).', 'timeFrame': '6 months'}, {'measure': 'the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'the of sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).', 'timeFrame': '6 months'}, {'measure': 'the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Probe-based Confocal Laser Endomicroscopy', 'the Operative Link on Gastric Intestinal Metaplasia']}, 'descriptionModule': {'briefSummary': 'Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients scheduled for pCLE examination will be recruited in this study at Qilu Hospital, Shandong University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 40 years or older with Helicobacter pylori infection;\n* Histologically verified GIM, atrophic gastritis or dysplasia.\n\nExclusion Criteria:\n\n* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;\n* Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;\n* Pregnancy or breastfeeding;\n* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.'}, 'identificationModule': {'nctId': 'NCT02932735', 'briefTitle': 'The Efficacy of Probe-based Confocal Laser Endomicroscopy in Staging OLGIM', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'orgStudyIdInfo': {'id': '2016SDU-QILU-18'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Li Yanqing, MD, PhD', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-531-82169236'}], 'overallOfficials': [{'name': 'Li Yanqing, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}