Each year, approximately 400 Australian women are diagnosed with vulvar cancer.
The standard treatment of vulvar cancer includes surgery to remove the primary tumour plus the groin lymph nodes. Groin lymph nodes are removed because having them analysed by a pathologist is currently the only way to identify if the cancer has spread to the groin lymph nodes. While this treatment is often curative, the removal of the groin lymph nodes is associated with debilitating lifelong side effects, including painful and disfiguring limb swelling (lymphoedema), compromised function, impaired mobility and greater susceptibility to infection. An estimated 2,500 Australian women currently live with these debilitating conditions as a result of vulvar cancer treatment.
Pre-ANVU is a small study of 50 women that aims to review the feasibility of using ultrasound to check the groin lymph nodes for cancer. Currently, the trial is running at multiple sites in Queensland and will be expanded to include other sites in the Northern Territory, New South Wales, Victoria, and Tasmania soon.
Women who meet the eligibility criteria will receive a bilateral groin node ultrasound up to 14 days before planned surgery. The ultrasound reports will not change the actual treatment of each patient. Women with vulvar cancer will also have a blood test pre-surgery and six weeks post-surgery to initiate research on a novel blood tumour marker for vulvar cancer, which unfortunately does not exist currently.
The NODE (groiN ultrasOunD cancEr) study will run concurrently to pre-ANVU. NODE will determine the feasibility of randomising 20 women with vulvar cancer into either surgical removal of groin lymph nodes (standard care) or groin node ultrasound (groin lymph nodes are not removed) at sites in Queensland. This study will road-test operating procedures and patient information materials in preparation for a subsequent large randomised controlled clinical trial.
