Groin ultrasound and fine needle aspiration cytology in the conservative management of the groin nodes in primary squamous cell cancer of the vulva

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82982873

Enrollment

Registered

2004-09-30

Start date

2003-05-01

Completion date

Unknown

Last updated

2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer: Vulva Cancer Primary squamous cell carcinoma of the vulva

Interventions

Randomised, non-blinded (Phase 2): Groin node surgery (GS) versus no groin node surgery (NGS)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Not provided at time of registration

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026