Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-05 @ 9:17 PM
Study NCT ID:
NCT03289468
Status:
UNKNOWN
Last Update Posted:
2019-08-07
First Post:
2017-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014591', 'term': 'Uterine Diseases'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'FirstXianJiaotongU'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-04', 'studyFirstSubmitDate': '2017-06-15', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The endometrial vascularization index', 'timeFrame': 'From March 2019 to December 2019', 'description': 'The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).'}], 'secondaryOutcomes': [{'measure': 'The ultrasonography of endometrium', 'timeFrame': 'From March 2019 to December 2019', 'description': 'The ultrasonography of endometrium included shape, boundary and echo.'}, {'measure': 'The endometrial thickness', 'timeFrame': 'From March 2019 to December 2019', 'description': 'The endometrial thickness in centimeter.'}, {'measure': 'The blood flow index of endometrium', 'timeFrame': 'From March 2019 to December 2019', 'description': 'The blood flow index include peak systolic velocity(PSV),cm/s, end diastolic velocity(EDV) ,cm/s, mean flow velocity(MnV) ,cm/s, pulsatility index(PI), resistance index(RI).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Diseases']}, 'descriptionModule': {'briefSummary': 'The postmenopausal women with vaginal bleeding were selected in this cross-sectional study. The basic characteristics information and endometrial blood flow energy index of endometrium were detected by color power Doppler ultrasound, and the energy histogram of endometrium was obtained. The specimen of uterine cytology and endometrial tissue were obtained through minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical data were used to detect endometrial and precancerous lesions to observe the endpoint, and to provide the energy histogram model of the early warning endothelial diseases.', 'detailedDescription': 'The postmenopausal women with vaginal bleeding are selected in this cross-sectional study. The uterine bleeding in patients with blood system diseases, reproductive organ outside the uterus, other organs cancer metastasis to the uterus are excluded. The objects are divided into two groups(patients with endometrial benign diseases and patients with endometrial cancer and precancerous diseases) according to endometrial cytological and histological pathology. The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. Moreover,The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which were diagnosed by pathology.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women with vaginal bleeding', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women with vaginal bleeding\n\nExclusion Criteria:\n\n* Vaginal bleeding caused by hematological system diseases or genitals outside the uterus\n* Uterine bleeding caused by other organ cancers metastasize to the uterus'}, 'identificationModule': {'nctId': 'NCT03289468', 'briefTitle': 'Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases', 'orgStudyIdInfo': {'id': 'XJTU1AF-CRF-2016T-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1', 'description': 'Endometrial Benign Disease', 'interventionNames': ['Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler']}, {'label': 'Group2', 'description': 'Endometrial Cancer and Precancerous Lesions', 'interventionNames': ['Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler']}], 'interventions': [{'name': 'Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler', 'type': 'DIAGNOSTIC_TEST', 'description': 'The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which are diagnosed by pathology.', 'armGroupLabels': ['Group1', 'Group2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng YANG', 'role': 'CONTACT', 'email': 'yxf73@163.com'}], 'facility': "First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Xiaofeng YANG, Doctor', 'role': 'CONTACT', 'email': 'yxf73@163.com', 'phone': '0086-18602900810'}], 'overallOfficials': [{'name': 'Xiaofeng YANG, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Xian Jiaotong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}