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

NCT05576831 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2026-02-03

No results posted yet for this study

Summary

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 vulvar cancer, and consequently many women may be overtreated, and many women are not treated enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no longer be appropriate. The investigators aim in this study is to see if personalizing surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve outcomes.

Conditions

  • Vulvar Cancer

Interventions

PROCEDURE

Re-excision

Re-excise (one take back only) Excise scar aiming for 1-2cm margin

Sponsors & Collaborators

  • Gynecologic Cancer Initiative

    collaborator OTHER

  • Australia New Zealand Gynaecological Oncology Group

    collaborator OTHER

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Amy Jamieson, MD · BC Cancer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2031-11-25
Completion
2031-11-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05576831 on ClinicalTrials.gov