Active Surveillance: The investigator will follow the patient to watch for side effects and keep track of patient's health
Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance — 3 years
Trial sites (12)
Facility
City
Region
Status
BCCA - Kelowna
Kelowna
British Columbia
Recruiting
BCCA - Vancouver
Vancouver
British Columbia
Recruiting
BCCA - Victoria
Victoria
British Columbia
Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton
Ontario
Recruiting
Odette Cancer Centre
Toronto
Ontario
Recruiting
University Health Network
Toronto
Ontario
Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal
Quebec
Recruiting
The Jewish General Hospital
Montreal
Quebec
Recruiting
Hotel-Dieu de Quebec
Québec
Quebec
Recruiting
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke
Quebec
Recruiting
Allan Blair Cancer Centre
Regina
Saskatchewan
Recruiting
Auckland City Hospital
Auckland
New Zealand
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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