Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04810702
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2021-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Von Willebrand Factor and Its Multimers on Angiogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014842', 'term': 'von Willebrand Diseases'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'frozen plasma fractions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-08-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the relationship between proteins involved in angiogenesis and the distribution of multimers in patients with von Willebrand disease in order to define markers of interest', 'timeFrame': '1 year', 'description': 'Compare the distribution of multimers assays between different groups of patients and the control group'}, {'measure': 'To study the relationship between proteins involved in angiogenesis and the distribution of multimers in patients with von Willebrand disease in order to define markers of interest', 'timeFrame': '1 year', 'description': 'Compare the distribution of protein assays between different groups of patients and the control group'}], 'secondaryOutcomes': [{'measure': 'To study the relationship between the distribution of multimers and the clinical phenotype of patients, and in particular the presence of angiodysplasias', 'timeFrame': '1 year', 'description': 'To study the correlation between the clinical phenotype and the assays of angiogenesis proteins'}, {'measure': 'To study the relationship between the markers of interest and the clinical phenotype of patients, and in particular the presence of angiodysplasias', 'timeFrame': '1 year', 'description': 'To study the correlation between the clinical phenotype and the distribution of multimers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Von Willebrand Diseases']}, 'descriptionModule': {'briefSummary': 'The study aims to study the expression of numerous proteins involved in angiogenesis in 70 patients with von Willebrand disease in order to try to identify markers of interest. Secondly, the investigators plan to investigate whether there is a relationship between the proteins tested, the distribution of multimers and the clinical phenotype of the patients, in particular by looking for the presence of bleeding linked to the presence of angiodysplasias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The studied population will be composed of:\n\n* 70 patients with von Willebrand disease: 10 type 1 patients, 10 type 2A (IIA) patients, 10 type 2A (IIE) patients, 10 type 2B patients, 10 type 2M patients, 10 type 2M patients (2A-like) and 10 type 3 patients.\n* 20 healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patients:\n\n* Patient with von Willebrand disease proven by genetic analysis of the VWF gene.\n* Lack of treatment that could interfere with angiogenesis.\n* Patient informed by an information note sent to his home, with the possibility of objecting to the use of his blood samples in the context of research.\n\nFor the control:\n\n* Patient with a normal coagulation report\n* Absence of abnormal hemorrhagic symptoms\n* Lack of notion of angiodysplasia.\n* Lack of treatment that could interfere with angiogenesis.\n* Patient informed by an information note sent to his home, with the possibility of objecting to the use of his blood samples in the context of research.\n\nExclusion Criteria:\n\n* Patient under guardianship or curatorship.\n* Pregnant and lactating women.\n* Blood transfusion or treatment with von Willebrand factor concentrates less than 7 days old.\n* Treatment which may interfere with angiogenesis.'}, 'identificationModule': {'nctId': 'NCT04810702', 'acronym': 'WILLANGIO', 'briefTitle': 'Impact of Von Willebrand Factor and Its Multimers on Angiogenesis', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Impact of Von Willebrand Factor and Its Multimers on Angiogenesis', 'orgStudyIdInfo': {'id': 'RC20_0531'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with von Willebrand disease', 'interventionNames': ['Other: no intervention']}, {'label': 'case control', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['case control', 'patients with von Willebrand disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc Fouassier', 'role': 'CONTACT', 'email': 'marc.fouassier@chu-nantes.fr)', 'phone': '0240084049'}, {'name': 'Marc Fouassier', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}