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Clinical Trials in Canada / NCT06358469
Recruiting Not applicable

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

NCT06358469 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2024-12-10
Last updated
2026-08-11

Condition(s) studied

Vulvar Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

SurgeryActive Surveillance

Surgery: Re-excision of vulvar cancer margin

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)

Trial sites (12)

FacilityCityRegionStatus
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

More Canadian Cancer Trials Group trials in Canada

Official registry record

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.

View NCT06358469 on ClinicalTrials.gov ↗ ← All trials in Canada