Groin ultrasound and fine needle aspiration cytology in the conservative management of the groin nodes in primary squamous cell cancer of the vulva
ISRCTN | ISRCTN82982873 |
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DOI | https://doi.org/10.1186/ISRCTN82982873 |
Secondary identifying numbers | N0258123595 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 20/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Desmond Barton
Scientific
Scientific
Gynaecology Unit
Royal Marsden NHS Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Phone | +44 (0)20 7352 8171 |
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desmond.barton@rmh.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Groin ultrasound and fine needle aspiration cytology in the conservative management of the groin nodes in primary squamous cell cancer of the vulva |
Study objectives | 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). |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cancer: Vulva |
Intervention | Randomised, non-blinded (Phase 2): Groin node surgery (GS) versus no groin node surgery (NGS) |
Intervention type | Other |
Primary outcome measure | 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 |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/05/2003 |
Completion date | 31/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Female |
Target number of participants | Total number Royal Marsden Hospital (RMH) patients 40 |
Key inclusion criteria | Not provided at time of registration |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/05/2003 |
Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Marsden NHS Trust
London
SW3 6JJ
United Kingdom
SW3 6JJ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.dh.gov.uk/Home/fs/en |
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Funders
Funder type
Government
The Royal Marsden NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
20/04/2018: No publications found, verifying study status with principal investigator.
23/03/2016: No publications found, verifying study status with principal investigator.