Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 8:17 AM
Study NCT ID:
NCT02996734
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2016-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018212', 'term': 'Giant Cell Tumor of Bone'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D005870', 'term': 'Giant Cell Tumors'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003475', 'term': 'Curettage'}, {'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 412}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local recurrence rate after surgical and medical treatment', 'timeFrame': 'within the first 36 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bone tumors', 'giant cell tumor', 'treatment'], 'conditions': ['Giant Cell Tumor of Bone']}, 'referencesModule': {'references': [{'pmid': '30099641', 'type': 'DERIVED', 'citation': 'Tsukamoto S, Mavrogenis AF, Leone G, Righi A, Akahane M, Tanzi P, Kido A, Honoki K, Tanaka Y, Donati DM, Errani C. Denosumab does not decrease the risk of lung metastases from bone giant cell tumour. Int Orthop. 2019 Feb;43(2):483-489. doi: 10.1007/s00264-018-4085-6. Epub 2018 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to present the outcomes of patients with giant cell tumor of bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.', 'detailedDescription': 'The investigators retrospectively review patients treated for GCTB of the extremities between 1990 and 2013 in a single institution. We evaluate the recurrence free survival rate after surgical and medical treatment of patients with GCTB of the extremities to determine the influence of the surgical approach, denosumab therapy, local tumor presentation, and demographic factors on the risk of recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with giant cell tumor of bone treated in a single institution', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* giant cell tumors of the extremities\n\nExclusion Criteria:\n\n* giant cell tumors of the spine and pelvis'}, 'identificationModule': {'nctId': 'NCT02996734', 'acronym': 'GCTLIMBS', 'briefTitle': 'Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Il Tumore a Cellule Giganti Delle estermità', 'orgStudyIdInfo': {'id': '0008286'}}, 'armsInterventionsModule': {'interventions': [{'name': 'curettage and resection', 'type': 'PROCEDURE', 'otherNames': ['denosumab'], 'description': 'the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Davide Donati, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'publish a manuscript in international medical journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD; PhD.', 'investigatorFullName': 'Costantino Errani', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}