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

Launched by CANADIAN CANCER TRIALS GROUP · Apr 5, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision," is exploring whether some early-stage vulvar cancers need different treatments than what is usually given. Researchers want to find out if certain types of vulvar squamous cell carcinoma (VSCC) can be treated with less or more intense care based on specific characteristics of the cancer, like HPV status and p53 status. The study is currently looking for female participants aged 18 and older who have been diagnosed with early-stage VSCC that has not spread to other areas of the body and who are eligible for surgery.

If you join this trial, you will undergo a standard surgery for your cancer, and your doctors will assess the cancer's characteristics afterward. Participants will also be asked to complete questionnaires about their quality of life, which helps researchers understand how the treatment affects everyday living. It's important to note that this study is not for those with recurrent VSCC or certain other types of cancer. By participating, you could help researchers learn more about tailoring treatment for vulvar cancer, potentially improving care for future patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed primary 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