Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT04846556
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2021-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study', 'timeFrame': 'Up to 6 months after venous thromboembolic event', 'description': 'Patient having at least one of the following exclusion criteria (from CARAVAGGIO study) :\n\n* ECOG (Eastern Cooperative Oncology Group ) Performance Status III or IV;\n* life expectancy of less than 6 months;\n* thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;\n* indication for anticoagulant treatment for a disease other than the index VTE episode;\n* thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;\n* recent brain, spinal or ophthalmic surgery\n* hemoglobin level lower than 8 g/dL or platelet count \\<75x10\\^9/L or history of heparin induced thrombocytopenia;\n* creatinine clearance \\< 30 ml /min\n* acute hepatitis, chronic active hepatitis, liver cirrhosis;\n* uncontrolled hypertension;\n* concomitant use of strong inhibitors or inducers of cytochrome;\n* bacterial endocarditis;'}], 'secondaryOutcomes': [{'measure': 'Drugs used for their VTE', 'timeFrame': 'Up to 6 months after venous thromboembolic event', 'description': 'Collected in medical history.'}, {'measure': 'Confirmed recurrent Venous Thromboembolic Event (VTE)', 'timeFrame': 'Up to 6 months after venous thromboembolic event', 'description': 'Collected in medical history.\n\n* Pulmonary embolism\n* deep venous thrombosis'}, {'measure': 'Bleeding event', 'timeFrame': 'Up to 6 months after venous thromboembolic event', 'description': 'Collected in medical history.'}, {'measure': 'Death', 'timeFrame': 'Up to 6 months after venous thromboembolic event', 'description': 'Collected in medical history.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'thrombosis', 'epidemiology', 'cancer-associated venous thromboembolism (CAT)', 'venous thromboembolic event'], 'conditions': ['Venous Thromboembolism', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.\n\nGuidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.\n\nHowever, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.\n\nNevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.\n\nThe proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.', 'detailedDescription': 'The aim of this study si to assess this proportion in a retrospective multicenter study, of patients admitted for acute Cancer-Associated venous Thromboembolism (CAT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted for a venous thromboembolic event related to their cancer will be included between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nConsecutive patients with a newly diagnosed, objectively confirmed:\n\n* symptomatic or unsuspected Deep Vein Thrombosis (DVT) (any location)\n* symptomatic or unsuspected Pulmonary Embolism (PE)\n\nConsecutive patients with any type of cancer whose primary brain tumor or known intracerebral metastases and acute leukemia that meets at least one of the following:\n\n* Active cancer defined as diagnosis of cancer within six months or receiving treatment for cancer or any treatment for cancer or recurrent locally advanced or metastatic cancer.\n* Cancer diagnosed within 2 years.\n\nExclusion Criteria:\n\n* pregnant women or breast feeding'}, 'identificationModule': {'nctId': 'NCT04846556', 'briefTitle': 'Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Cancer Associated Thrombosis: What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO (a Retrospective Multicenter Study)', 'orgStudyIdInfo': {'id': 'IRBN352021/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'venous thromboembolic event related to cancer', 'description': 'Patients admitted for a venous thromboembolic event related to their cancer will be included A data collection will be realized. Patients admitted between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital.', 'interventionNames': ['Other: data collection']}], 'interventions': [{'name': 'data collection', 'type': 'OTHER', 'description': 'data collection : gender, weight, biological data (platelets, hemoglobin, creatinine, liver function tests), performance status, type of Venous Thromboembolic Event (VTE) and cancer, anticancer and anticoagulant therapy, adverse events (bleeding, recurrence of Venous Thromboembolic Event (VTE), death) up to 6 months after their Venous Thromboembolic Event (VTE).', 'armGroupLabels': ['venous thromboembolic event related to cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '92000', 'city': 'Colombes', 'country': 'France', 'facility': 'Hôpital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Laurent Bertoletti, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}