RecruitingNot ApplicableNCT06358469
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
Sponsor
Canadian Cancer Trials Group
Enrollment
249 participants
Start Date
Dec 10, 2024
Study Type
INTERVENTIONAL
Conditions
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?
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria7
- 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
Exclusion Criteria7
- 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.
Interventions
PROCEDURESurgery
Re-excision of vulvar cancer margin
OTHERActive Surveillance
The investigator will follow the patient to watch for side effects and keep track of patient's health
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06358469