RecruitingNot ApplicableNCT05576831

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

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


Sponsor

British Columbia Cancer Agency

Enrollment

249 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the extent of re-excision surgery can be guided by HPV status and p53 protein testing in women with early-stage vulvar cancer (cancer of the external female genitalia). The aim is to avoid unnecessary surgery while still ensuring cancer-free margins. **You may be eligible if...** - You are 18 or older - You have been diagnosed with early-stage vulvar squamous cell carcinoma (FIGO stage I or II) - You have already had your primary surgery but the margins are very close to or involve certain pre-cancerous changes - Your tumor has been classified as either HPV-independent or HPV-associated by testing **You may NOT be eligible if...** - You have advanced or metastatic vulvar cancer - You cannot provide consent or comply with study requirements - You do not meet specific margin criteria defined by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERe-excision

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


Locations(1)

BC Cancer - Vancouver Centre

Vancouver, British Columbia, Canada

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NCT05576831


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