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
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

Gynaecology Unit
Royal Marsden NHS Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom

Phone	+44 (0)20 7352 8171
Email	desmond.barton@rmh.nhs.uk

Study information

Study design	Randomised controlled trial
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
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

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The Royal Marsden NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
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.