Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT06358469
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06358469
Study Brief:
Protocol Section:
NCT06358469