Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-01 @ 6:41 PM
Study NCT ID:
NCT04512495
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2020-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D007890', 'term': 'Leiomyosarcoma'}, {'id': 'D008080', 'term': 'Liposarcoma'}, {'id': 'D018208', 'term': 'Liposarcoma, Myxoid'}, {'id': 'D013584', 'term': 'Sarcoma, Synovial'}, {'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D012512', 'term': 'Sarcoma, Ewing'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.', 'timeFrame': '6 months after the end of inclusions'}], 'secondaryOutcomes': [{'measure': 'Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.', 'timeFrame': '6 months after the end of inclusions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leiomyosarcoma', 'Dedifferentiated liposarcoma', 'Myxoid liposarcoma', 'Synovialosarcoma', 'Osteosarcoma', "Ewing's sarcoma", 'Cancer cell/macrophage hybrid cells', 'Hybrid cells'], 'conditions': ['Sarcoma']}, 'descriptionModule': {'briefSummary': 'Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood.\n\nThe study will be conducted on a population of patients with sarcoma and treated in the context of routine care.\n\nFor each included patient, blood samples will be collected during baseline visit and after the initiation therapy.\n\nAt the end of the 2nd blood collection, the patient will have completed his participation in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.\n2. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)\n3. Age ≥ 18 years old.\n4. Localized or metastatic disease or recurrent disease.\n5. Patient who has not yet initiated specific treatment for sarcoma.\n6. Patient affiliated to a Social Health Insurance in France.\n7. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.\n\nExclusion Criteria:\n\n1. Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.\n2. Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.\n3. Pregnant or breastfeeding woman.\n4. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.\n5. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)."}, 'identificationModule': {'nctId': 'NCT04512495', 'acronym': 'SAMHY SARCOME', 'briefTitle': 'Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?', 'orgStudyIdInfo': {'id': '20 SARC 04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with sarcoma', 'interventionNames': ['Other: Blood samples will be collected at two times :']}], 'interventions': [{'name': 'Blood samples will be collected at two times :', 'type': 'OTHER', 'description': '* at Baseline,\n* after surgery or at the time of post-chemotherapy evaluation.', 'armGroupLabels': ['Patients with sarcoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Universitaire du Cancer de Toulouse - Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}