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New treatment option for Vulvar Cancer
Official title STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
ClinicalTrials.gov ID: NCT05576831
What this study is testing
- What it's testing
- Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials.
- Which group you join is decided by chance.
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 primary diagnosis of vulvar squamous cell carcinoma
- Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
- Margin status after primary surgery:
- HPV-I VSCC: margins are negative for cancer but \<8mm, and/or positive for dVIN, and/or positive for p53 abnormality on IHC
- HPV-A VSCC: margins are negative for cancer but \<8mm (regardless of in-situ (HSIL) margin status)
You likely can't join if
- Recurrent vulvar squamous cell carcinoma
- Non-squamous cell carcinoma histotypes
- FIGO stage III- IV disease
- Patients referred for adjuvant radiation for close margins
- Margins positive for cancer
See the full eligibility criteria
- Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma
- Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
- Margin status after primary surgery:
- HPV-I VSCC: margins are negative for cancer but \<8mm, and/or positive for dVIN, and/or positive for p53 abnormality on IHC
- HPV-A VSCC: margins are negative for cancer but \<8mm (regardless of in-situ (HSIL) margin status)
- Age ≥18 years old
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to...
- Recurrent vulvar squamous cell carcinoma
- Non-squamous cell carcinoma histotypes
- FIGO stage III- IV disease
- Patients referred for adjuvant radiation for close margins
- Margins positive for cancer
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
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 Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.