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ISRCTN
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ISRCTN79422566
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DOI
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10.1186/ISRCTN79422566
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Port-a-cath and Hickman line devices for chemotherapy delivery
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Scientific title
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Port-a-cath and Hickman line devices for chemotherapy delivery: A randomised phase II study and pre-trial economic model development to inform the design of a subsequent randomised phase III controlled trial
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Acronym
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N/A
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Serial number at source
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Protocol/Serial No: MI93
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Study hypothesis
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The study hypothesis is that Ports are cost effective for the delivery of chemotherapy and that it is not appropriate to deny these devices to patients on grounds of purchasing costs alone. Although Ports are a little more difficult to insert and more expensive than Hickman lines, they carry potential advantages such as reduced infection and re-intervention rates, reduced maintenance and superior patient acceptability.
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Lay summary
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http://www.cancerresearchuk.org/cancer-help/trials/a-study-comparing-two-different-types-central-lines-people-due-start-course-chemotherapy
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Ethics approval
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West of Scotland REC 1, 5th April 2011, ethics reference number: 11/AL/0083
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Study design
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Multi-centre open randomised study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer, Chemotherapy, device study
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Participants - inclusion criteria
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1. Oncology patients with solid tumours who are scheduled for access line insertion
2. Patients must be willing and clinically able to receive either a Hickman line or a Port-a-cath
3. Patient must provide informed consent
4. Age ≥18 years, male and female
5. Able to comply with study protocol
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Participants - exclusion criteria
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1. Any evidence of any medical or psychiatric disorders that would be a contra indication to study participation
2. Life expectancy < 3 months
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Anticipated start date
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01/08/2011
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Anticipated end date
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31/07/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please contact Judith Dixon [judith.dixon@glasgow.ac.uk] to request a patient information sheet
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Target number of participants
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100
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Interventions
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Patients will be randomised in a 3:1 ratio to receive either a Hickman line (n=75) or a Port-a-cath (n=25).
Patients participating in the study will be asked to complete quality of life questionnaires (EQ-5D and device-specific) at baseline and subsequently monthly (sent out to the patients at home) during the insertion period; a further questionnaire will be completed at the time of planned line removal.
Patients will be seen as per standard of care for their treatment. Complication forms will be completed on a monthly basis by CTU Glasgow staff.
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Primary outcome measure(s)
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Cost effectiveness of Ports
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Secondary outcome measure(s)
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Complication data including line infection (with and without antibiotics), tract infection, (with/without antibiotics), occlusion, migration, loss of line, central vein thrombosis, exit site haematoma, and skin breakdown will be recorded by clinical staff, on complication forms in case notes, as events occur and data collected by the clinical trial coordinator. Reinterventions including line replacement, thrombolysis, stripping and manipulations will be recorded by clinical staff, on complication forms in case notes, as events occur and data collected by the clinical trial coordinator.
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Sources of funding
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Chief Scientist Office (UK) - Scottish Government (CZG/2/512)
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Trial website
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Publications
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Contact name
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Prof
Jonathan
Moss
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Address
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Dept of Radiology
Gartnavel General Hospital
1053 Great Western Road
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City/town
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Glasgow
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Zip/Postcode
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G12 0DY
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Country
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United Kingdom
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Email
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jon.moss@ggc.scot.nhs.uk
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Sponsor
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NHS Greater Glasgow and Clyde (UK)
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Address
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c/o Dr Nathaniel Brittain
Academic Research Co-ordinator
Research and Development
Western Infirmary
Dumbarton Road
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City/town
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Glasgow
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Zip/Postcode
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G11 6NT
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Country
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United Kingdom
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Email
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Nathaniel.Brittain@ggc.scot.nhs.uk
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Sponsor website:
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http://www.nhsggc.org.uk
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Date applied
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25/01/2013
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Last edited
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06/03/2013
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Date ISRCTN assigned
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06/03/2013
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