Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06017518
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study of Local Relapse After High Grade Osteosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'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': 'D012509', 'term': 'Sarcoma'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-10', 'size': 429973, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-24T04:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post local relapse survival', 'timeFrame': '24 months follow up', 'description': 'the aim of the study is to analyse the factors influencing post local relapse survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteosarcoma']}, 'descriptionModule': {'briefSummary': 'multicenter retrospective and prospective study in patients with high-grade osteosarcoma', 'detailedDescription': 'This is a multicenter retrospective and prospective study that will analyze all cases with of diagnosis of local relapse in high-grade osteosarcoma from 01 January 1980 and all new cases referring to each participant site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who experienced local relapse as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who experienced LR as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases\n* Adequate patient compliance to follow-up visits\n* Written informed consent prior to any study-specific analysis and/or data collection\n* No age limits\n\nExclusion Criteria:\n\n* Cases of LR demonstrated after \\> 3 months after metastatic disease\n* Impossibility to ensure adequate compliance'}, 'identificationModule': {'nctId': 'NCT06017518', 'acronym': 'OSTEO LR', 'briefTitle': 'An Observational Study of Local Relapse After High Grade Osteosarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'An Observational Study of Local Relapse After High Grade Osteosarcoma', 'orgStudyIdInfo': {'id': 'OSTEO LR'}}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'state': 'BO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuela Palmerini, MD', 'role': 'CONTACT', 'email': 'emanuela.palmerini@ior.it', 'phone': '051/6366', 'phoneExt': '668'}], 'facility': 'IRCCS Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '56126', 'city': 'Pisa', 'state': 'PI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Coccoli, MD', 'role': 'CONTACT', 'email': 'l.coccoli@ao-pisa.toscana.it'}], 'facility': 'Azienda Ospedaliero-Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'centralContacts': [{'name': 'Emanuela Palmerini, MD', 'role': 'CONTACT', 'email': 'emanuela.palmerini@ior.it', 'phone': '051/6366', 'phoneExt': '668'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}