Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT07093320
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Saving Limbs After Cancer: Blood Vessel and Soft Tissue Reconstruction Following Sarcoma Surgery in the Legs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'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': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1- Limb salvage rate 2- Flap survival 3- Vascular patency', 'timeFrame': 'At 12 months postoperatively', 'description': '1. Limb salvage: Determined by clinical documentation of limb preservation without major amputation.\n2. Flap survival: Determined by clinical evaluation of flap viability\n3. Vascular patency: Determined by duplex ultrasonography or CT angiography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue Sarcoma (STS)']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate whether immediate reconstruction of blood vessels and soft tissues can safely and effectively preserve limbs in patients undergoing surgery for sarcomas involving major arteries or veins in the arms or legs. The goal was to determine if this complex surgical approach helps avoid amputation, ensures good cancer control, and leads to acceptable complication rates and healing outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Tertiary center (sarcoma reference center), teaching hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patient presented with STS with major vessels involvement\n\nExclusion Criteria:\n\n* All STS without major vessels involvement'}, 'identificationModule': {'nctId': 'NCT07093320', 'acronym': 'SARCOVASCPLAST', 'briefTitle': 'Saving Limbs After Cancer: Blood Vessel and Soft Tissue Reconstruction Following Sarcoma Surgery in the Legs', 'organization': {'class': 'OTHER', 'fullName': 'European Georges Pompidou Hospital'}, 'officialTitle': 'Immediate Vascular and Soft Tissue Reconstruction After Sarcoma Resection Involving Major Limb Vessels: Early and Midterm Outcomes From a Tertiary Center', 'orgStudyIdInfo': {'id': 'SARCOVAPLAST'}, 'secondaryIdInfos': [{'id': 'number IRB 00006477', 'type': 'OTHER', 'domain': 'Hôpitaux Universitaires Paris Nord Val de Seine AP-HP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'STS with major vessel involvement', 'description': 'STS with major vessel involvement', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['STS with major vessel involvement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Martin LHUAIRE, MD, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015'}, {'name': 'Laurent Lantieri, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015'}, {'name': 'David BIAU, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Service de Chirurgie Orthopédique et oncoorthopédie, Hôpital Cochin, Paris, , France 75015'}]}, 'ipdSharingStatementModule': {'url': 'https://www.aphp.fr', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '12 months after publication of the data', 'ipdSharing': 'YES', 'accessCriteria': 'De-identified individual participant data (IPD) and supporting documentation will be made available by the Principal Investigator upon reasonable request from qualified researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Georges Pompidou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Martin Lhuaire', 'investigatorAffiliation': 'European Georges Pompidou Hospital'}}}}