NCT06358469

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

This study is being done to find out if these approaches are better or worse than the usual approach for early-stage vulvar cancer. The usual approach is defined as care most people get for early-stage vulvar cancer. The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor in deciding whether additional surgery should be recommended. For patients deciding to take part in this study, the treatment that will be recommended will be based on laboratory testing of the cancer. The laboratory assessments include a test to determine if the cancer is caused by the Human Papilloma Virus (HPV) or not caused by HPV. If the laboratory test results show the vulvar cancer is caused by HPV, the study doctor will recommend the patient participate in sub-study A. In sub-study A, the patient will receive no additional surgery (observation). If the laboratory test results show the vulvar cancer is not caused by HPV, the study doctor will recommend the patient participate in sub-study B. In sub-study B, patients will receive either a second surgery or no additional surgery (observation).

Conditions

• Vulvar Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Surgery	Re-excision of vulvar cancer margin
OTHER	Active Surveillance	The investigator will follow the patient to watch for side effects and keep track of patient's health

Timeline

• Start date: 2024-12-10
• Primary completion: 2030-06-30
• Completion: 2031-11-30
• First posted: 2024-04-10
• Last updated: 2026-04-14

Locations

10 sites across 2 countries: Canada, New Zealand