Status:
NOT_YET_RECRUITING
Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Vulvar HSIL
HPV
Eligibility:
FEMALE
18-100 years
Phase:
PHASE4
Brief Summary
Problem description: Yearly, approximately 45000 women develop vulvar cancer worldwide. It is estimated that about 30% of all vulvar carcinomas are HPV related. As with other HPV related (pre)maligna...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Women 18 years or older
- Vulvar High-grade Squamous Intraepithelial Lesion (vHSIL), histologically proven
- Planned for treatment (surgical, laser or imiquimod) for vHSIL
- Exclusion criteria
- Prior HPV vaccination
- (Micro-) invasive carcinoma or history of HPV related genital carcinoma (cervix, anal, vulva)
- Pregnancy
- Women allergic to vaccine components
- HIV infection
- Immune compromised patients (currently on immunosuppressive medication
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06052696
Start Date
December 1 2023
End Date
December 1 2030
Last Update
September 25 2023
Active Locations (1)
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1
Erasmus MC
Rotterdam, Netherlands