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

Launched by BRITISH COLUMBIA CANCER AGENCY · Oct 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how to better treat vulvar squamous cell carcinoma, a type of cancer that affects the outer genital area in women. Researchers have discovered that this cancer can develop in two main ways: one linked to a virus called HPV and the other related to long-term skin inflammation, which is not associated with HPV. Because these two types of cancer behave differently and respond to treatment in unique ways, the trial aims to see if personalizing surgical treatment based on whether the cancer is HPV-related or not, and the presence of specific genetic changes, can lead to better outcomes for patients.

To be eligible for this trial, participants should be women aged 18 or older with a confirmed diagnosis of early-stage vulvar squamous cell carcinoma. They must also meet specific criteria regarding their surgery results, such as having certain conditions with their cancer margins. Women who have recurrent cancer or more advanced disease are not eligible. If someone joins the trial, they will receive tailored treatment based on their cancer type, which could help avoid both under-treatment and over-treatment. Overall, this study could lead to more effective and personalized care for women with vulvar cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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