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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleGroin ultrasound and fine needle aspiration cytology in the conservative management of the groin nodes in primary squamous cell cancer of the vulva
Study objectivesTo 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) studiedCancer: Vulva
InterventionRandomised, non-blinded (Phase 2): Groin node surgery (GS) versus no groin node surgery (NGS)
Intervention typeOther
Primary outcome measureIf 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 measuresNot provided at time of registration
Overall study start date01/05/2003
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participantsTotal number Royal Marsden Hospital (RMH) patients 40
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/05/2003
Date of final enrolment31/12/2006

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.