Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-04-14 @ 2:05 PM
Study NCT ID:
NCT02407535
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2015-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor invasion', 'timeFrame': 'Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)', 'description': 'Tumor invasion (in millimeters and in percentage of myometrial size) as assessed by ultrasound in comparison to macroscopic assesment during surgery and to final pathological report)'}]}, 'conditionsModule': {'conditions': ['Endometrial Endometroid Carcinoma']}, 'descriptionModule': {'briefSummary': "In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient's age is 18 or above\n2. Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms.\n3. Patient able to understand,read and sign informed consent.\n4. Patient is not participating in other medical trials at present or in the past 30 days\n\nExclusion Criteria:\n\n1. Age under 18 years\n2. Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma\n3. Subjects which their biopsy in the pre operating process will include high risk cell types:\n\n * Grade 3 endometrioid adenocarcinoma,\n * clear cell carcinoma\n * papillary serous carcinoma\n * carcinosarcoma"}, 'identificationModule': {'nctId': 'NCT02407535', 'briefTitle': 'Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium', 'orgStudyIdInfo': {'id': 'CMC-14-0059-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endometrial carcinoma patient', 'interventionNames': ['Device: Intraoperative ultrasound']}], 'interventions': [{'name': 'Intraoperative ultrasound', 'type': 'DEVICE', 'description': 'Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion', 'armGroupLabels': ['Endometrial carcinoma patient']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Ido Feferkorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ido Feferkorn', 'investigatorAffiliation': 'Carmel Medical Center'}}}}