Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-04-23 @ 8:09 AM
Study NCT ID:
NCT03169595
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epithelioid Hemangioma of Bone And Soft Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000796', 'term': 'Angiolymphoid Hyperplasia with Eosinophilia'}], 'ancestors': [{'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006099', 'term': 'Granuloma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-26', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-05-26', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multifocal presentation of patients with epithelioid hemangioma of bone and soft tissue without producing a fatal outcome', 'timeFrame': '2 years', 'description': 'The investigators defined multifocal presentation the presence of secondary lesions by imaging at presentation of the disease or during follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epithelioid Hemangioma of Bone', 'Epithelioid Hemangioma']}, 'descriptionModule': {'briefSummary': 'The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat aggressive clinical characteristics, including multifocal presentation and occasional lymph node involvement.\n\nThe investigators reviewed the clinicopathologic and radiologic characteristics of bone and soft tissue epithelioid hemangioma in patients treated at our institution with available tissue for molecular testing.\n\nThe hypothesis is that epithelioid hemangioma may present with multifocal involvement and rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent prognosis.', 'detailedDescription': 'The investigators retrospectively reviewed patients treated for epithelioid hemangioma of the bone and soft tissue in a single insitution. The purpose of this study is to evaluate the pathological, clinical, and radiological characteristics of epithelioid hemangioma arising within bone and soft tissue, in the first cohort of cases where the definitive diagnosis is supplemented by molecular techniques.\n\nThe hypothesis is that the improved knowledge regarding this rare entity can more definitively elucidate the benign biology of epithelioid hemangioma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with epithelioid hemangioma of bone and soft tissue treated in a single institution', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with epithelioid hemangioma of bone and soft tissue in the extremities and pelvis\n\nExclusion Criteria:\n\n* patients with epithelioid hemangioma of bone and soft tissue in the spine'}, 'identificationModule': {'nctId': 'NCT03169595', 'acronym': 'EE-META', 'briefTitle': 'Epithelioid Hemangioma of Bone And Soft Tissue', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Epithelioid Hemangioma of Bone And Soft Tissue: a Benign Tumor With Metastatic Potential', 'orgStudyIdInfo': {'id': '0033566'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Patients affected by epithelioid hemangioma treated with surgery'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Davide Donati, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'publish a manuscript in international journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD.', 'investigatorFullName': 'Costantino Errani', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}