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โ† Trials
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STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

RecruitingNAAges 18 Years - anyFemaleCanadian Cancer Trials Group
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In plain words

What the trial is, and whether it could suit you

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?

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 5 years * Lymph node positive VSCC or lymph nodes with isolated tumour cells.
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What it tests

  • Surgery
  • Active Surveillance
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Where

12 sites
BCCA - Kelowna
Kelowna, Canada
BCCA - Vancouver
Vancouver, Canada
BCCA - Victoria
Victoria, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Canada
Odette Cancer Centre
Toronto, Canada
University Health Network
Toronto, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Canada
The Jewish General Hospital
Montreal, Canada

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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