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

Vulvar Squamous Cell Carcinoma

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?

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Conditions de participation

  • Sexe:

    FEMALE
  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:

* Histologically confirmed primary 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

Lieu de l'étude

BCCA - Vancouver
BCCA - Vancouver
Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Amy Jamieson

604 729-1258
Étude parrainée par
Canadian Cancer Trials Group
Participants recherchés
Plus d'informations
ID de l'étude: NCT06358469