Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT03284320
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2017-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Study in Sarcoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 514}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- Progression free survival (PFS)', 'timeFrame': 'At the time of every treatment documentation up to the end of treatment, approximately 2 years'}, {'measure': '- Overall survival (OS)', 'timeFrame': 'At the time of every treatment documentation up to the end of treatment, approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'CTCAE (Common Terminology Criteria for Adverse Events) 4.03', 'timeFrame': 'At the time of every treatment documentation up to the end of treatment, approximately 2 years', 'description': 'Safety Evaluation according to toxitiy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy', 'Treatment outcome', 'Adult'], 'conditions': ['Sarcoma of Bone', 'Sarcoma of Soft Tissue']}, 'referencesModule': {'references': [{'pmid': '22868503', 'type': 'BACKGROUND', 'citation': 'Pink D, Bertz-Lepel J, Busemann C, Bitz U, Reichardt P. Efficacy of trabectedin in patients with advanced or metastatic alveolar soft-part sarcoma. Onkologie. 2012;35(5):249-52. doi: 10.1159/000338342. Epub 2012 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin in a large cohort of German patients with soft tissue and bone sarcomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with soft tissue and bone sarcomas treated with Trabectedin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed soft tissue or bone sarcomas treated with at least one cycle of Trabectedin in any line of therapy.\n* Age ≥18years at start of therapy with Trabectedin\n* Informed Consent\n* Patients already deceased may be included when the treating physician is able to determine the presumptive consent\n\nExclusion Criteria:\n\n* No follow-up data available'}, 'identificationModule': {'nctId': 'NCT03284320', 'acronym': 'ReTraSarc', 'briefTitle': 'Retrospective Study in Sarcoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients', 'orgStudyIdInfo': {'id': 'GISG-14'}}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'University Medicine Greifswald, Department of Internal Medicine C', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'overallOfficials': [{'name': 'Daniel Pink, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medicine Greifswald'}, {'name': 'Peter Reichardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'PharmaMar', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}