Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT03977818
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2019-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.italiano@bordeaux.unicancer.fr', 'phone': '33 5 56 33 33 33', 'title': 'Pr Antoine Italiano', 'organization': 'Institut Bergonié'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013', 'description': 'Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 satisfying all eligibility criteria', 'otherNumAtRisk': 2165, 'otherNumAffected': 0, 'seriousNumAtRisk': 2165, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013', 'description': 'Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '0.78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'TNT: time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.\n\nOS: time from the systemic treatment onset to death', 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013', 'description': 'Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2165', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013', 'description': 'Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'title': '< 75 years', 'measurements': [{'value': '1886', 'groupId': 'BG000'}]}, {'title': '>= 75 years', 'measurements': [{'value': '279', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1110', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1055', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '2165', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1990-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2019-05-23', 'resultsFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2020-11-25', 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment', 'timeFrame': '2 years', 'description': 'TNT: time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.\n\nOS: time from the systemic treatment onset to death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['outcome', 'time to next treatment', 'overall survival', 'patterns of care'], 'conditions': ['Sarcoma', 'Metastases', 'Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '28391775', 'type': 'RESULT', 'citation': 'Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.'}]}, 'descriptionModule': {'briefSummary': 'Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals.\n\nThe patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug.\n\nOutcome (time-to-next treatment \\[TNT\\] and overall survival \\[OS\\]) will be reported according to histological subtype, as well as the association between TNT and OS.\n\nPrognostic factors of OS will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'advanced soft tissue sarcoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced soft tissue sarcoma\n* age \\> 18\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03977818', 'acronym': 'METASARC', 'briefTitle': 'Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Patterns of Care and Outcomes of Patients With METAstatic Soft Tissue SARComa in a Real-life Setting: the METASARC Observational Study', 'orgStudyIdInfo': {'id': 'IB2017-METASARC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié, Comprehensive Cancer Center', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard, Comprehensive Cancer Center', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy, Comprehensive Cancer Center', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Antoine Italiano, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Bergonié, Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Sarcoma Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}