Actively Recruiting
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
Led by British Columbia Cancer Agency · Updated on 2026-02-03
249
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
B
British Columbia Cancer Agency
Lead Sponsor
G
Gynecologic Cancer Initiative
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma
- Surgically staged FIGO I-II disease
- Margin status after primary surgery: HPV-I VSCC with margins negative for cancer but less than 8mm, and/or positive for differentiated vulvar intraepithelial neoplasia, and/or positive for p53 abnormality on immunohistochemistry
- Margin status after primary surgery: HPV-A VSCC with margins negative for cancer but less than 8mm regardless of high-grade squamous intraepithelial lesion margin status
- Age 18 years or older
- Patient consent obtained in accordance with local and regulatory requirements
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BC Cancer - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 2E6
Actively Recruiting
Research Team
A
Amy Jamieson, MD
CONTACT
J
Jessica McAlpine, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here