STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
NCT ID: NCT06358469
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
249 participants
INTERVENTIONAL
2024-12-10
2031-11-30
Brief Summary
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Detailed Description
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The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor in deciding whether additional surgery should be recommended.
For patients deciding to take part in this study, the treatment that will be recommended will be based on laboratory testing of the cancer. The laboratory assessments include a test to determine if the cancer is caused by the Human Papilloma Virus (HPV) or not caused by HPV. If the laboratory test results show the vulvar cancer is caused by HPV, the study doctor will recommend the patient participate in sub-study A. In sub-study A, the patient will receive no additional surgery (observation). If the laboratory test results show the vulvar cancer is not caused by HPV, the study doctor will recommend the patient participate in sub-study B. In sub-study B, patients will receive either a second surgery or no additional surgery (observation).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sub-Study A: Active Surveillance
If the laboratory test results show vulvar cancer is caused by HPV
Active Surveillance
The investigator will follow the patient to watch for side effects and keep track of patient's health
Sub-Study B: Re-excision
If the laboratory test results show vulvar cancer is not caused by HPV
Surgery
Re-excision of vulvar cancer margin
Sub-Study B: Active Surveillance
If the laboratory test results show vulvar cancer is not caused by HPV
Active Surveillance
The investigator will follow the patient to watch for side effects and keep track of patient's health
Interventions
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Active Surveillance
The investigator will follow the patient to watch for side effects and keep track of patient's health
Surgery
Re-excision of vulvar cancer margin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Australia New Zealand Gynaecological Oncology Group
OTHER
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Amy Jamieson
Role: STUDY_CHAIR
University of British Columbia, Vancouver, BC, Canada
Jessica McAlpine
Role: STUDY_CHAIR
BCCA-Vancouver Cancer Centre, Vancouver, BC Canada
Locations
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BCCA - Vancouver
Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Hotel-Dieu de Quebec
Québec, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, Canada
Auckland City Hospital
Auckland, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Amy Jamieson
Role: primary
Julie My Van Nguyen
Role: primary
Lilian Gien
Role: primary
Stephane Laframboise
Role: primary
Annick Pina
Role: primary
Marie Plante
Role: primary
Paul Bessette
Role: primary
Lois Eva
Role: primary
Other Identifiers
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VU2
Identifier Type: -
Identifier Source: org_study_id
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