NCT06358469 STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
| NCT ID | NCT06358469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Canadian Cancer Trials Group |
| Condition | Vulvar Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 249 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 249 participants in total. It began in 2024-12-10 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 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 or lymph nodes with isolated tumour cells.
Contact & Investigator
Amy Jamieson
STUDY CHAIR
University of British Columbia, Vancouver, BC, Canada
Frequently Asked Questions
Who can join the NCT06358469 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vulvar Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06358469 currently recruiting?
Yes, NCT06358469 is actively recruiting participants. Contact the research team at wparulekar@ctg.queensu.ca for enrollment information.
Where is the NCT06358469 trial being conducted?
This trial is being conducted at Kelowna, Canada, Vancouver, Canada, Hamilton, Canada, Toronto, Canada and 7 additional locations.
Who is sponsoring the NCT06358469 clinical trial?
NCT06358469 is sponsored by Canadian Cancer Trials Group. The principal investigator is Amy Jamieson at University of British Columbia, Vancouver, BC, Canada. The trial plans to enroll 249 participants.