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
Protocol serial number	N0258123595
Sponsor	Department of Health
Funder	The Royal Marsden NHS Trust (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

Royal Marsden NHS Trust

London
SW3 6JJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.