Stratifying vulvar squamous cell carcinoma by HPV and p53 to guide surgical excision

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective interventional study classifies vulvar squamous cell carcinomas by HPV (p16) and p53 status and applies predefined margin-based algorithms to direct decisions about re-excision. Patients with HPV-associated tumors may be offered less radical surgery when margins are close, while HPV-independent tumors with p53 abnormalities may be managed more aggressively to lower recurrence risk. The study records clinical outcomes and patient-reported outcomes including body image, sexual function, urinary symptoms, genital pain, and fear of recurrence. Outcomes for stratified management will be compared to standard approaches to see if changes in surgical extent improve recurrence rates and quality of life.

Why it matters

Who can join: the full rules

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

Where it's running

• BC Cancer - Vancouver Centre
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Amy Jamieson, MD — BC Cancer
• Study coordinator: Amy Jamieson, MD
• Email: Amy.Jamieson@vch.ca
• Phone: 604-875-4268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.