STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision

Recruiting now · Not applicable

Conditions studied: Vulvar Cancer

In brief

Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different pathways. One pathway is associated with human papillomavirus (HPV) infection, and another is related to chronic inflammatory skin conditions (and not HPV). The VSCCs arising from these two principal pathways; HPV- associated (HPV A) and HPV-independent (HPV I), behave differently with different risks of recurrence, and different response to treatments. HPV-I VSCC are further defined by mutations in TP53 (Tumor Protein 53), which identify a group of patients with aggressive disease. Currently treatment is the same for all women with vulvar cancer, and consequently many women may be overtreated, and many women are not treated enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no longer be appropriate. The investigators aim in this study is to see if personalizing surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve outcomes.

Key facts

Study ID

NCT05576831

Run by

British Columbia Cancer Agency

People needed

249

Starts

2024-11-25

Expected to finish

2031-11-25

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma
• Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
• Margin status after primary surgery:
• HPV-I VSCC: margins are negative for cancer but <8mm, and/or positive for dVIN, and/or positive for p53 abnormality on IHC
• HPV-A VSCC: margins are negative for cancer but <8mm (regardless of in-situ (HSIL) margin status)
• Age ≥18 years old
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.

You may not qualify if…

• Recurrent vulvar squamous cell carcinoma
• Non-squamous cell carcinoma histotypes
• FIGO stage III- IV disease
• Patients referred for adjuvant radiation for close margins
• Margins positive for cancer

Where it is running

• BC Cancer - Vancouver Centre — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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