Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT03523494
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2018-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-11-27', 'releaseDate': '2019-11-07'}, {'resetDate': '2020-04-03', 'releaseDate': '2020-03-23'}], 'estimatedResultsFirstSubmitDate': '2019-11-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'International Society of Lymphology stage', 'timeFrame': '1 week', 'description': 'stage Ia, Ib, IIa, IIb, IIIa, and IIIb'}, {'measure': 'lymphascintigraphy stage', 'timeFrame': '1 week', 'description': 'Normal: 1; delayed flow, but visible axillary lymph or inguinal lymph node: 2; , invisible axillary lymph or inguinal lymph node: 3: visible dermal backflow: 4'}, {'measure': 'circumference between normal and involved limbs', 'timeFrame': '1 week', 'description': '5cm above and below mid-antecubital or mid-popliteal fossa'}], 'primaryOutcomes': [{'measure': 'Reticulation Ratio from Computerized Tomography', 'timeFrame': '1 week', 'description': 'calculated value of reticulation'}], 'secondaryOutcomes': [{'measure': 'Multi-frequency bio-electric impedance analysis', 'timeFrame': '1 week', 'description': 'comparative ratio using 1KHz'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphedema', 'Secondary Lymphedema', 'CT']}, 'referencesModule': {'references': [{'pmid': '31821335', 'type': 'DERIVED', 'citation': 'Koo KI, Ko MH, Lee Y, Son HW, Lee S, Hwang CH. Comparison of a novel algorithm quantitatively estimating epifascial fibrosis in three-dimensional computed tomography images to other clinical lymphedema grading methods. PLoS One. 2019 Dec 10;14(12):e0224457. doi: 10.1371/journal.pone.0224457. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Development of lympho-proliferation reticulation quantification using CT.', 'detailedDescription': 'It is known that fibrosis of the subcutaneous soft tissue progresses over time in the lymph edema, and this change progresses to reticulation pattern.\n\nAuthors will develop a digital subtraction technique for the extraction of lympho-proliferative reticulation using the Housfield unit of non-reticulation structure (bones, muscles, tendons, vessels, nerves) in the axial image of CT.\n\nBased on the medical records, authors will develop an early diagnosing tool by checking the correlation of the values derived the new technique with circumference, multi-frequency bio-electric impedance analysis, ISO sub-stage, and lymphascintigraphy, and qualify the cut-off values showing high sensitivity and specificity through the receiver operating characteristics (ROC) curve analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs\n\nExclusion Criteria:\n\n* Primary lymph edema (congenital lymph edema, lymph edema precox, lymph edema tarda)\n* Lymph edema simultaneously involving both limbs\n* Patients who undertook implantation of electrical devices such as cardic pacemakers'}, 'identificationModule': {'nctId': 'NCT03523494', 'briefTitle': 'Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Ulsan University Hospital'}, 'officialTitle': 'Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography.', 'orgStudyIdInfo': {'id': 'chhwang9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal limb', 'description': 'Normal'}, {'label': 'Abnormal limb', 'description': 'Lymph Edema'}]}, 'contactsLocationsModule': {'locations': [{'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Chang Ho Hwang, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ulsan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, PhD and MD', 'investigatorFullName': 'Chang Ho Hwang', 'investigatorAffiliation': 'Ulsan University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-11-07', 'type': 'RELEASE'}, {'date': '2019-11-27', 'type': 'RESET'}, {'date': '2020-03-23', 'type': 'RELEASE'}, {'date': '2020-04-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chang Ho Hwang, MD, PhD., Associate professor, PhD and MD, Ulsan University Hospital'}}}}