Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT06709833
Status:
RECRUITING
Last Update Posted:
2025-01-06
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue factor', 'timeFrame': 'duration of surfical tumor resection (a few hours)', 'description': 'Concentration of tissue factor at pre-surgery and immediately after tumor resection (during close-up).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meningeoma', 'thrombembolism', 'tissue-factor'], 'conditions': ['Meningeoma', 'Thrombembolism', 'Surgical Resection']}, 'descriptionModule': {'briefSummary': 'Despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. The molecular mechanisms underlying this circumstance are still unknown.\n\nIn this prospective observational trial, the investigators aim to evaluate the changes in coagulation and platelet function caused by tumor resection.\n\nBlood samples are obtained by patients undergoing meningioma resection before and immediately after resection to detect said changes.\n\nAs a control cohort, blood samples are obtained from patients undergoing resection for glioma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intracranial tumors\n\n1. meningeoma\n2. glioma (control)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing resection for meningioma or\n* Patients undergoing resection for glioma or\n* Healthy controls\n* written consent for study participation\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06709833', 'acronym': '001_2024_BO2', 'briefTitle': 'Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation', 'orgStudyIdInfo': {'id': '001_2024_BO2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Meningioma resection', 'description': 'patients undergoing resection for meningioma'}, {'label': 'Glioma resection', 'description': 'Patients undergoing glioma resection as a control cohort for meningioma patients'}, {'label': 'Healthy controls', 'description': 'Healthy controls without tumor and surgical resection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alice Bernard, MD', 'role': 'CONTACT', 'email': 'alice.bernard@med.uni-tuebingen.de', 'phone': '0049-7071-2968029'}], 'facility': 'University Hospital for Anaesthesiology and Intensive Care Medicine, Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Michael Koeppen, MD', 'role': 'CONTACT', 'email': 'michael.koeppen@med.uni-tuebingen.de', 'phone': '+4970712986935'}, {'name': 'Alice Bernard, MD', 'role': 'CONTACT', 'email': 'alice.bernard@med.uni-tuebingen.de', 'phone': '+4970712968028'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}