Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT00851305
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2009-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020699', 'term': 'Gastroscopes'}], 'ancestors': [{'id': 'D020776', 'term': 'Endoscopes, Gastrointestinal'}, {'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1786}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2009-02-24', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stomach', 'endoscopy', 'neoplasms'], 'conditions': ['Stomach Neoplasms', 'Precancerous Conditions']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).', 'detailedDescription': 'Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 45 years old ≤ age \\< 80 years old\n* Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy\n\nExclusion Criteria:\n\n* Known cancers or gastrectomy\n* Scheduled for endoscopic treatment\n* Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss\n* Under conditions such as:\n\n * ascites\n * jaundice\n * liver cirrhosis\n * impaired renal function\n * coagulopathy\n * fever\n * pregnancy\n * breastfeeding\n* Inability to provide informed consent\n* Known allergy to fluorescein sodium'}, 'identificationModule': {'nctId': 'NCT00851305', 'acronym': 'CLE', 'briefTitle': 'Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers', 'orgStudyIdInfo': {'id': '2008SDU-QILU-G01'}, 'secondaryIdInfos': [{'id': '2006GG3202022'}, {'id': '2007(Ministry of Health)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 confocal laser endomicroscopy', 'description': 'Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.', 'interventionNames': ['Device: Endomicroscope (Pentax, Tokyo, Japan)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Conventional endoscopy', 'description': 'Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.', 'interventionNames': ['Device: Gastroscopes (Pentax, Tokyo, Japan)']}], 'interventions': [{'name': 'Endomicroscope (Pentax, Tokyo, Japan)', 'type': 'DEVICE', 'otherNames': ['Pentax EC3870K endomicroscope'], 'description': 'A Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm.', 'armGroupLabels': ['1 confocal laser endomicroscopy']}, {'name': 'Gastroscopes (Pentax, Tokyo, Japan)', 'type': 'DEVICE', 'otherNames': ['Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)'], 'description': 'Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)', 'armGroupLabels': ['2 Conventional endoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], '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': 'Chief of the Department of Gastroenterology', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}