Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-26 @ 10:06 PM
Study NCT ID:
NCT05357768
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2022-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-06', 'size': 436436, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-21T11:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'event free survival', 'timeFrame': 'baseline', 'description': 'Correlate clinical and pathological variables with event-free survival and overall-survival in undifferentiated round cell sarcomas.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Undifferentiated Round Cell Sarcoma']}, 'descriptionModule': {'briefSummary': 'Experimental study with biological material : case series review of clinical and histological data', 'detailedDescription': 'This is a multicenter retrospective and prospective study that will analyze all cases with a diagnosis of Undifferentiated round cell sarcomas from 01 January 1983 and all new cases referring to each participant site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male and femalke patient without limit of age with a diagnosis of undifferentiated round cell sarcomas treated from 01 January 1983 and all new cases referring to each participant site.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with undifferentiated round cell sarcomas treated from 01 January 1983 and all new patients will be included.\n* Clinical and outcome information available.\n* Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis/frozen tissue representative of the tumor available.\n\nExclusion Criteria:\n\n* Diagnosis different from undifferentiated round cell sarcomas\n* Patient with no clinical or outcome information available'}, 'identificationModule': {'nctId': 'NCT05357768', 'acronym': 'GRACefUl', 'briefTitle': 'Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project', 'orgStudyIdInfo': {'id': 'GRACefUl'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'retrospective cohort', 'description': 'Patients with undifferentiated round cell sarcomas treated from 01 January 1983 to April 2019 will be included.\n\nFor retrospective analysis, it is expected to include about 200 patients.', 'interventionNames': ['Other: data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue']}, {'label': 'prospective cohort', 'description': 'prospective patients with undifferentiated round cell sarcomas will be included in the study. For prospective study, it is expect to include 60 patients.', 'interventionNames': ['Other: data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue']}], 'interventions': [{'name': 'data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue', 'type': 'OTHER', 'description': "Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue of cases negative for all Ewing's sarcoma molecular fusions, will be analyzed for the presence of CIC-DUX4 / BCOR-CCNB3 translocations fusion at each Institution.\n\nTreatment, outcome, and prognostic factors will be related with the molecular re-classification.", 'armGroupLabels': ['prospective cohort', 'retrospective cohort']}]}, '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': '051.63.66', 'phoneExt': '199'}, {'name': 'Emanuela Palmerini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCs Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Emanuela Palmerini, MD', 'role': 'CONTACT', 'email': 'emanuela.palmerini@ior.it', 'phone': '051.63.66', 'phoneExt': '199'}, {'name': 'Marco Gambarotti, MD', 'role': 'CONTACT', 'email': 'marco.gambarotti@ior.it', 'phone': '051.63.66', 'phoneExt': '652'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}