Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-04 @ 3:39 PM
Study NCT ID:
NCT05455866
Status:
UNKNOWN
Last Update Posted:
2022-07-13
First Post:
2022-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Venous Catheter-related Complications in Patients Under Anticancer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056824', 'term': 'Upper Extremity Deep Vein Thrombosis'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062905', 'term': 'Central Venous Catheters'}], 'ancestors': [{'id': 'D062666', 'term': 'Vascular Access Devices'}, {'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-08', 'studyFirstSubmitDate': '2022-07-08', 'studyFirstSubmitQcDate': '2022-07-08', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate and density of central venous catheter-related complications (infections, thromboses, extravasation)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Incidence rate of severe central venous catheter-related complications', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Venous Catheter Thrombosis', 'Central Venous Catheter Related Bloodstream Infection', 'Solid Tumor', 'Hematologic Malignancy']}, 'descriptionModule': {'briefSummary': "Oncology and hemotology patients under anticancer treatments are exposed to increased risks of central venous catheter-related complications due to the underlying cancer and its treament.\n\nThis prospective observational monocentric french study aims at describing the incidence of such complications, their morbimortality, and analyzing some risk factors in order to contribute to propose some strategies to reduce these complications' rate and consequences"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients at Oncohematology Outpatient Department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients older than 18 years, with solid cancer or hematological malignancy receiving anticancer treatment in the outpatient medical department of Alpes Leman Hospital and having a central venous catheter been placed between the 11th of July 2022, and the 1st of January 2023.'}, 'identificationModule': {'nctId': 'NCT05455866', 'acronym': 'KTcCHO', 'briefTitle': 'Central Venous Catheter-related Complications in Patients Under Anticancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Alpes Leman'}, 'officialTitle': 'Central Venous Catheter-related Complications in Patients Under Anticancer Treatment: a Prospective Monocentric Study on Incidence and Consequences', 'orgStudyIdInfo': {'id': 'KTcCHO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'central venous catheter', 'type': 'DEVICE', 'description': 'collection and descriptionof central venous catheter-related complications'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Florence OBERKAMPF', 'role': 'CONTACT', 'email': 'foberkampf@ch-alpes-leman.fr', 'phone': '+33 4 50 82 22 72'}], 'overallOfficials': [{'name': 'Florence OBERKAMPF', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Alpes Leman'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Alpes Leman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}