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ISRCTN
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ISRCTN82982873
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ClinicalTrials.gov identifier
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Public title
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Groin ultrasound and fine needle aspiration cytology in the conservative management of the groin nodes in primary squamous cell cancer of the vulva
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0258123595
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Study hypothesis
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To compare groin and lower limb morbidity in the groin surgery group (GS) and the non-groin surgery group (NGS). Comparison of quality of life between the two groups. Events will be recorded for all patients (such as time to local or regional recurrence).
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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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: Vulvar
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/05/2003
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Total number Royal Marsden Hospital (RMH) patients 40
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Interventions
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Randomised, non-blinded (Phase 2): Groin node surgery (GS) versus no groin node surgery (NGS)
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Primary outcome measure(s)
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If this study shows that in patients with squamous cell cancer of the vulva and with a negative groin USS and FNAC groin node surgery can be safely avoided then this will have a major impact in the following areas:
1. Improved quality of life with patient morbidity
2. Increased demand on the radiology services and, in pairticular, a need for a dedicated radiologist to undertake the initial USS assessment and subsequent USS surveillance. Such skills should be available in a Cancer Centre treating gynaecological cancer patients.
3. Potentially this study could lead to a fundamental change in the management of the groin nodes in vulval cancer
4. Likely reduction in hospitalisation following surgery
5. Likely reduction in the time to return to work and/or return to normal activities
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The Royal Marsden NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
Desmond
Barton
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Address
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Gynaecology Unit
Royal Marsden NHS Trust
Fulham Road
Chelsea
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City/town
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London
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Zip/Postcode
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SW3 6JJ
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Country
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United Kingdom
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Tel
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+44 (0)20 7352 8171
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Fax
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+44 (0)20 7808 2048
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Email
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desmond.barton@rmh.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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25/10/2011
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Date ISRCTN assigned
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30/09/2004
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