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

RecruitingNAAges 18 Years - anyFemaleBritish Columbia Cancer Agency
NCT05576831 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 vulva

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📋 Eligibility rules (as published)
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
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What it tests

  • Re-excision
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Where

1 site
BC Cancer - Vancouver Centre
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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