STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

Recruiting now · Not applicable

Conditions studied: Vulvar Squamous Cell Carcinoma

In brief

This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?

Key facts

Study ID

NCT06358469

Run by

Canadian Cancer Trials Group

People needed

249

Starts

2024-12-10

Expected to finish

2031-11-30

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Auckland City Hospital — Auckland, New Zealand (enrolling)
• BCCA - Vancouver — Vancouver, British Columbia, Canada (enrolling)
• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada (enrolling)
• Odette Cancer Centre — Toronto, Ontario, Canada (enrolling)
• University Health Network — Toronto, Ontario, Canada (enrolling)
• CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (enrolling)
• BCCA - Kelowna — Kelowna, British Columbia, Canada (enrolling)
• Hotel-Dieu de Quebec — Québec, Quebec, Canada (enrolling)
• CIUSSS de l'Estrie - Centre hospitalier — Sherbrooke, Quebec, Canada (enrolling)
• Allan Blair Cancer Centre — Regina, Saskatchewan, Canada (enrolling)
• The Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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