Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06244420
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2024-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Malignant Myoepithelioma of Bone and Soft Tissues: Diagnostic Imaging and Histology in Relation to Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009208', 'term': 'Myoepithelioma'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation', 'timeFrame': 'At baseline (Day 0)', 'description': 'correlation between imaging and histology with prognosis in patients with soft tissue and bone MC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myoepithelioma']}, 'referencesModule': {'references': [{'pmid': '33526224', 'type': 'RESULT', 'citation': 'Xu B, Katabi N. Myoepithelial Carcinoma. Surg Pathol Clin. 2021 Mar;14(1):67-73. doi: 10.1016/j.path.2020.09.008. Epub 2021 Jan 5.'}, {'pmid': '25299310', 'type': 'RESULT', 'citation': 'Thway K, Fisher C. Myoepithelial tumor of soft tissue: histology and genetics of an evolving entity. Adv Anat Pathol. 2014 Nov;21(6):411-9. doi: 10.1097/PAP.0000000000000039.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess whether there is a correlation between imaging and histology with prognosis in patients with soft tissue and bone MC from the archives of the Rizzoli Orthopaedic Institute all the patients with a histological diagnosis of soft tissue or bone malignant myoepithelioma treated from 1998 to 2021'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with soft tissue and bone MC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients treated at Rizzoli Orthopaedic Institute between 01 Jan 1998 and 31 Dec 2021\n* Age ≥ 2 years old\n* Diagnosis of soft tissue or bone malignant myoepithelioma (MC-SB)\n* Patients with available clinical and imaging data\n\nExclusion Criteria:\n\n* At least one inclusion criterion not met'}, 'identificationModule': {'nctId': 'NCT06244420', 'briefTitle': 'Malignant Myoepithelioma of Bone and Soft Tissues: Diagnostic Imaging and Histology in Relation to Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Malignant Myoepithelioma of Bone and Soft Tissues: Diagnostic Imaging and Histology in Relation to Prognosis', 'orgStudyIdInfo': {'id': 'MYO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'patients with a histological diagnosis of soft tissue or bone malignant myoepithelioma treated from 1998 to 2021.', 'interventionNames': ['Other: Clinical data review']}], 'interventions': [{'name': 'Clinical data review', 'type': 'OTHER', 'description': 'review the medical records, radiological imaging, and histological data of these patients', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'IRCCS Itituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}