Assessing treatment needs for early-stage vulvar cancer based on HPV and p53 status

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 study aims to determine if early-stage vulvar squamous cell carcinoma (VSCC) patients require different treatment approaches based on laboratory testing of their cancer. Patients will be categorized into two sub-studies depending on whether their cancer is caused by the Human Papilloma Virus (HPV). Those with HPV-related cancer will be monitored without additional surgery, while those without HPV may undergo further surgical intervention or observation. The goal is to tailor treatment to individual patient needs, potentially improving outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed diagnosis of vulvar squamous cell carcinoma (VSCC)
* Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines
* Vulvar resection according to standard of care guidelines
* Post-operative margin assessment of tumour clearance, dVIN and p53 status.
* Participants' age must be ≥ 18 years old
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French
* Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements

Exclusion Criteria:

* Recurrent vulvar squamous cell carcinoma
* Non-squamous cell carcinoma histotypes
* Participants referred for/receiving/or previously received adjuvant vulvar radiation or chemotherapy
* Primary tumour HPV-I p53 wild-type VSCC
* Surgical margins positive for invasive cancer.
* Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years
* Lymph node positive VSCC or lymph nodes with isolated tumour cells.

Where it's running

• BCCA - Kelowna
  Kelowna, British Columbia, Canada Recruiting
• BCCA - Vancouver
  Vancouver, British Columbia, Canada Recruiting
• BCCA - Victoria
  Victoria, British Columbia, Canada Recruiting
• Juravinski Cancer Centre at Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting
• Odette Cancer Centre
  Toronto, Ontario, Canada Recruiting
• University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Wendy Parulekar
• Email: wparulekar@ctg.queensu.ca
• Phone: 613-533-6430

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.