Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-04 @ 4:22 AM
Study NCT ID:
NCT03855969
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2019-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Venous Access Device Removal in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1402}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suspected infection rate', 'timeFrame': '2012-2017', 'description': 'How many central venous access devices are removed due to a suspected infection of the device in cancer patients.'}], 'secondaryOutcomes': [{'measure': 'Approved infection rate', 'timeFrame': '2012-2017', 'description': 'For how many of the central venous access devices that were removed due to suspected infection of the device could an infection be confirmed?'}, {'measure': 'Risk factors for central venous access device infections in cancer patients', 'timeFrame': '2012-2017', 'description': 'Is it possible to denote certain variables as potential risk factors for central venous access device infection?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PAC infections', 'oncology'], 'conditions': ['Oncology', 'Haematological Malignancy']}, 'descriptionModule': {'briefSummary': 'Background:\n\nCentral venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for contrast during medical imaging. In addition, this means more comfort for the patient who needs to be punctured less peripherally. However, central venous catheters can also be a source of bloodstream infections and other complications, leading to increased morbidity and hospital costs (1). In our hospital, there is a general practice that if an infection of the device is suspected, the central venous catheter should be removed if antibiotics do not seem or prove to be effective.\n\nThe objective of this trial is to assess the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device in a particular oncology center over a time period of seven years. Furthermore, evidence for real device infections (per/post-surgery) and the potential contribution of different (institution-specific) risk factors on device infection will be explored. There will be focused on implanted port catheters only, as this is the main used central venous access device within the oncological population.\n\nTrial objectives:\n\nThe primary aim of this retrospective descriptive trial is to evaluate the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device, over a time period of seven years.\n\nThe secondary aim is to examine whether the device infection could be confirmed during or after removal of the device.\n\nAt last, the tertiary aim is to verify whether certain variables can be denoted as potential risk factors for central venous access infection. Selection of those variables of interest will be based on a thorough review of the literature and discussion with the responsible healthcare professionals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We are interested in cancer patients who were implanted a central venous access device with regard to their cancer treatment, but for which the device was removed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Central venous access device removal in our general hospital\n* Cancer patient\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03855969', 'briefTitle': 'Central Venous Access Device Removal in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital Groeninge'}, 'officialTitle': 'Frequency of Central Venous Port Catheter Removal Due to Suspected Infection in Patients Diagnosed With Cancer at a Single Institution: A Retrospective Study.', 'orgStudyIdInfo': {'id': 'AZGS2018106'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Removal of a central venous access device', 'type': 'PROCEDURE', 'description': 'We are interested in those patients for which a central venous access device was removed.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'GHGroeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made publically and shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital Groeninge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Koen Van Eygen', 'investigatorAffiliation': 'General Hospital Groeninge'}}}}