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New treatment option for Vulvar Squamous Cell Carcinoma
Official title STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
ClinicalTrials.gov ID: NCT06358469
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- Lymph node positive VSCC or lymph nodes with isolated tumour cells.
The study team makes the final eligibility decision.
Where it's taking place
- Kelowna, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Regina, Saskatchewan, Canada
- Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.