Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT03598335
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2018-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterizing Malignant Tumors Using Ultrasound Doppler Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early characterization of malignant tumors', 'timeFrame': 'One year', 'description': 'Comparison of Ultrasound Doppler findings at different speeds between women without tumors, with benign tumors and with malignant tumors of reproductive system'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Malignant Tumor of Women's Reproductive System"]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether Ultrasound Doppler imaging can identify malignant tumors at a very early stage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women presenting at the Hillel Yaffe Medical Center gynecological ultrasound clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women presenting for routine abdominal/vaginal ultrasound\n\nExclusion Criteria:\n\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03598335', 'briefTitle': 'Characterizing Malignant Tumors Using Ultrasound Doppler Imaging', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Characterizing Malignant Tumors Using Ultrasound Doppler Imaging', 'orgStudyIdInfo': {'id': 'HYMC-0096-17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with malignant tumor', 'description': 'Women with malignant tumor in reproductive system', 'interventionNames': ['Device: Ultrasound']}, {'label': 'Women with benign tumor', 'description': 'Women with benign tumor in reproductive system', 'interventionNames': ['Device: Ultrasound']}, {'label': 'Women with no observed tumor', 'description': 'Women with no observed tumor in reproductive system', 'interventionNames': ['Device: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Ultrasound imaging of women arriving at clinic for routine care', 'armGroupLabels': ['Women with benign tumor', 'Women with malignant tumor', 'Women with no observed tumor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Genya Peisahov, BSc', 'role': 'CONTACT'}], 'facility': 'Hille Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Genya Peisahov, BSc', 'role': 'CONTACT', 'email': 'genyap@hymc.gov.il', 'phone': '972-54-8886349'}], 'overallOfficials': [{'name': 'Alon Shrim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}