Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04651569
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2020-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Evaluated during the first 4 months at the end of treatment', 'description': 'Disease remission or disease progression'}, {'measure': 'growth modulation index - GMI', 'timeFrame': 'Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)', 'description': 'ratio of time to progression (TTP) with nth line of therapy (TTPn) to the most recent prior line of therapy (TTPn-1)'}, {'measure': 'toxicity according to CTCAE v.5.0', 'timeFrame': 'Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)', 'description': 'Disease evaluation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteosarcoma Recurrent']}, 'descriptionModule': {'briefSummary': 'A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with relapsed/ refractory osteosarcom', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of high risk relapsed/ refractory osteosarcoma\n* Aged \\<= 40 years at the beginning of treatment\n* at least one completed cycle of HD IFO through elastomer (14g/mq) in 14 days\n* disease evaluation according to RECIST criteria v.1.1\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04651569', 'briefTitle': 'An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer', 'organization': {'class': 'OTHER', 'fullName': "Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna"}, 'officialTitle': 'A Multicentre, Retrospective, Observational Study to Analyse the Efficacy of High Dose Isofosfamide Administered Through Elastomer in Patients With Relapsed/ Refractory Osteosarcoma', 'orgStudyIdInfo': {'id': 'HD-IFOel'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'none, Observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Meyer', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00144', 'city': 'Roma', 'country': 'Italy', 'facility': 'Regina Elena National Cancer Institute IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'OIRM - AOU Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Celeste Cagnazzo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'A.O.U. Città della Salute e della Scienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Franca Fagioli', 'investigatorAffiliation': "Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna"}}}}