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

Study acronym: STRIVE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Dec 2025 to Nov 25, 2031 · Start date changed from estimate of Jan 1, 2025 to Nov 25, 2024 · Site details revisedv5 Show 3 more changesShow less
    • Primary and study completion dates: Dec 2025 to Nov 25, 2031
    • Start date changed from estimate of Jan 1, 2025 to Nov 25, 2024
    • Site details revised
  2. Start date: Jan 1, 2024 to Jan 1, 2025v4
  3. Start date: Jun 2023 to Jan 1, 2024v3
  4. Start date: Jan 2023 to Jun 2023 Primary endpoint revised · Secondary endpoints revised (6)v2 Show 2 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05576831
Lead Sponsor British Columbia Cancer Agency
Collaborators: Gynecologic Cancer Initiative, Australia New Zealand Gynaecological Oncology Group, Canadian Cancer Trials Group
Conditions Vulvar Cancer
Enrollment 249 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov