Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-29 @ 5:48 PM
Study NCT ID:
NCT05427461
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007890', 'term': 'Leiomyosarcoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2022-06-16', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.', 'timeFrame': '24 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': '24 months after the end of inclusions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leiomyosarcoma', 'Cancer cell/macrophage hybrid cells', 'Hybrid cells'], 'conditions': ['Leiomyosarcoma']}, 'descriptionModule': {'briefSummary': 'Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood and the evolution of this rate over time.\n\nThe study will be conducted on a population of patients with leiomyosarcoma and treated in the context of routine care. 20 patients will be included:\n\n* 10 patients with localized disease.\n* 10 patients with metastatic disease.\n\nFor each included patient, blood samples will be collected during baseline visit and up to 24 months after inclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient with leiomyosarcoma.\n2. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)\n3. Localized or metastatic disease\n4. Newly diagnosed patient who has not yet initiated specific treatment for sarcoma\n5. Age ≥ 18 years\n6. Patient affiliated to a Social Security system 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. Diagnosis of any other histological subtype of soft tissue sarcoma\n2. Associated pathology(ies) that may interfere with the study procedure\n3. Pregnant or breastfeeding woman\n4. Any psychological, family, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures provided for in 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': 'NCT05427461', 'acronym': 'SAMHY2', 'briefTitle': 'Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2', 'orgStudyIdInfo': {'id': '22 SARC 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient with leiomyosarcoma', 'interventionNames': ['Other: Blood samples will be collected at different times.']}], 'interventions': [{'name': 'Blood samples will be collected at different times.', 'type': 'OTHER', 'description': 'For patients with localized leiomyosarcoma, samples will be collected:\n\n* At Baseline.\n* Before surgery (for patients who have had neoadjuvant treatment (external radiotherapy and/or chemotherapy)).\n* After surgery.\n* At each control visit.\n* At local or metastatic recurrence (or at 24 months post inclusion if no progression).\n\nFor patients with metastatic leiomyosarcoma, samples will be collected:\n\n* At Baseline.\n* At each therapeutic line.\n* At progression (or at 24 months post inclusion if no progression).', 'armGroupLabels': ['Patient with leiomyosarcoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Universitaire du Cancer Toulouse - Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation ARC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}