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RECRUITING
NCT05576831
NA

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

Sponsor: British Columbia Cancer Agency

View on ClinicalTrials.gov

Summary

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.

Official title: STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision: STRIVE Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

249

Start Date

2024-11-25

Completion Date

2031-11-25

Last Updated

2026-02-03

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Re-excision

Re-excise (one take back only) Excise scar aiming for 1-2cm margin

Locations (1)

BC Cancer - Vancouver Centre

Vancouver, British Columbia, Canada