STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITING
Hamilton
CHUM-Centre Hospitalier de l'Universite de Montreal
RECRUITING
Montreal
Hotel-Dieu de Quebec
RECRUITING
Québec
CIUSSS de l'Estrie - Centre hospitalier
RECRUITING
Sherbrooke
Odette Cancer Centre
RECRUITING
Toronto
BCCA - Vancouver
RECRUITING
Vancouver
Contact Information
Primary
Wendy Parulekar
wparulekar@ctg.queensu.ca
613-533-6430
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2031-11-30
Participants
Target number of participants: 249
Treatments
Active_comparator: Sub-Study A: Active Surveillance
If the laboratory test results show vulvar cancer is caused by HPV
Active_comparator: Sub-Study B: Re-excision
If the laboratory test results show vulvar cancer is not caused by HPV
Active_comparator: Sub-Study B: Active Surveillance
If the laboratory test results show vulvar cancer is not caused by HPV
Sponsors
Collaborators: Australia New Zealand Gynaecological Oncology Group
Leads: Canadian Cancer Trials Group

This content was sourced from clinicaltrials.gov