Pre-ANVU Cohort Study

Vulvar cancer is a rare disease that, by its intimate nature, is also largely hidden from public discourse. Approximately 400 Australian women are diagnosed every year. Despite being rare, an estimated 2,500 Australian women currently live with the detrimental effects of vulvar cancer treatment. The current methods for treatment of vulvar cancer causes significant morbidity.

Standard treatment of vulvar cancer includes surgery to remove the primary tumour plus the removal of groin lymph nodes. While this treatment is often curative, removal of groin lymph nodes is associated with debilitating long-term outcomes, including painful and disfiguring limb swelling (lymphoedema), compromised function, impaired mobility and greater susceptibility to infection for virtually all women.

Women with vulvar cancer know and fear the outcomes of groin lymph node removal and describe life after this procedure as traumatic.

The aim of this feasibility study is to assess whether non-invasive groin ultrasound is a feasible and accurate method of predicting nodal involvement (i.e. the presence of cancer in groin lymph nodes) in vulvar cancer patients. If so, the ability to predict the absence of nodal involvement may spare future vulvar cancer patients’ unnecessary removal of groin lymph nodes to reduce complications, improve recovery time, and facilitate their return to normal daily activities.

An initial feasibility pilot cohort study was run in Queensland in 2022 and is now complete. Once deemed feasible and safe, we plan to achieve better short and long-term patient outcomes through evidence from the Australian National Vulvar Cancer trial.

Trial Sites

Recruitment

The Pre-ANVU trial opened for recruitment in August 2022.

Study 1: Feasibility of groin ultrasound to predict groin lymph node involvement in patients with histologically proven vulvar cancer

The study aims to recruit 50 participants from national and international sites. 37 participants have been enrolled to date.

Study 2: Feasibility of biomarker discovery in the differential diagnosis of VIN versus invasive vulvar cancer

The study aims to recruit 30 participants from national and international sites. Enrolment complete.