Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT06258694
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Venous Thrombo-Embolism Imaging Database (VTE-ID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VTE recurrence', 'timeFrame': 'At enrollment (retrospective follow up to 2 years)', 'description': 'VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis'}, {'measure': 'Distinguishing provoked from unprovoked VTE', 'timeFrame': 'At enrollment', 'description': 'Provoked VTE is defined by the presence within the three past months, of a major risk factor (i.e. Surgery, Immobilization \\> 3 days, Hormonal Treatment, Pregnancy, Cancer)'}], 'secondaryOutcomes': [{'measure': 'Individual phenotyping', 'timeFrame': 'At enrollment', 'description': 'Correlation of the identified biomarkers with VTE phenotypes (familial history, risk factor in case of provoked VTE, and biological biomarkers as fibrinogen, D Dimeres, Hemoglobin, Platelets, CRP, heterozygous or homozygous FV Leiden, Prothrombin G20210A).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venous thromboembolism', 'Image processing', 'Radiomics'], 'conditions': ['Venous Thromboembolism', 'Deep Vein Thrombosis', 'Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. To do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the VTE.', 'detailedDescription': 'Using a large imaging data in VTE (including ultrasound, CT-scan and Ventilation/Perfusion lung scan), the investigators will search for association between imaging data and VTE phenotypes, mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. Then, using a radiomic approach, the investigators will try to identify new imaging biomarkers able to provide an individual phenotyping in these patients.\n\nThese imaging biomarkers will be validated using an internal cross validation technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every patients included in the EDITH cohort between November 2009 and Novembre 2019, with a confirmed diagnosis of VTE.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older.\n* Confirmed VTE diagnosis (deep vein thrombosis or pulmonary embolism).\n* Inclusion in the EDITH (Etude des Déterminants et Interaction de la THrombose veineuse) between November 2009 and November 2019.\n* No opposition to be included in the present study.\n\nExclusion Criteria:\n\n* Patients under 18 years old.\n* Patients under judicial protection.\n* Patient physically or cognitively unable to give consent.\n* Refusal to participate.'}, 'identificationModule': {'nctId': 'NCT06258694', 'acronym': 'VTE-ID', 'briefTitle': 'Venous Thrombo-Embolism Imaging Database (VTE-ID)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Venous Thrombo-Embolism Imaging Database', 'orgStudyIdInfo': {'id': '29BRC20.0326 - VTE-ID'}}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'state': 'Finistere', 'country': 'France', 'facility': 'Brest University Hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}