Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-04-08 @ 5:21 AM
Study NCT ID:
NCT02955667
Status:
UNKNOWN
Last Update Posted:
2016-11-04
First Post:
2016-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2016-10-29', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic accuracy rate', 'timeFrame': '1 day (time of the examination)'}], 'secondaryOutcomes': [{'measure': 'image accordance rate', 'timeFrame': '1 day (time of the examination)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['invivo microscopy', 'colposcopy', 'cervical precancer and cancer'], 'conditions': ['Cervical Cancer', 'Cervical Precancer']}, 'descriptionModule': {'briefSummary': 'This study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells, which makes it possible to diagnose cervical cancer without wounds.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. cervical cytologic test result is HSIL\n2. persistent infection with high-risk HPV\n3. cervical pathological diagnosis is LSIL or HSIL\n\nExclusion Criteria:\n\n1. acute infection of lower genital tract\n2. the wound in lower genital tract\n3. active bleeding in lower genital tract'}, 'identificationModule': {'nctId': 'NCT02955667', 'briefTitle': 'The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer', 'orgStudyIdInfo': {'id': 'Fang Li'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'invivo microscopy group', 'description': 'patients receive invivo micro-colposcopy examination and do not have to receive the biopsies', 'interventionNames': ['Procedure: invivo microscopy group']}, {'type': 'OTHER', 'label': 'normal group', 'description': 'patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis', 'interventionNames': ['Procedure: normal group']}], 'interventions': [{'name': 'invivo microscopy group', 'type': 'PROCEDURE', 'description': 'patients receive invivo micro-colposcopy examination', 'armGroupLabels': ['invivo microscopy group']}, {'name': 'normal group', 'type': 'PROCEDURE', 'description': 'patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis', 'armGroupLabels': ['normal group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}