2023-506792-94-00招募中4 期
VulVaccin study: Adjuvant nonavalent HPV vaccination in women treated for vulvar HSIL, a Randomised Placebo Controlled Trial.
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)33 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2024年1月24日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 498
- 试验地点
- 33
- 主要终点
- Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between HPV vaccination and placebo up to 24 months post-treatment.
研究概览
简要总结
To evaluate the efficacy of adjuvant nonavalent HPV vaccination in women who will undergo treatment for (pathology proven) vulvar HSIL in preventing clinical recurrence HSIL up to 24 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years or older
- •Vulvar High-grade Squamous Intraepithelial Lesion (HSIL), histologically proven
- •Planned for treatment (surgical, laser or imiquimod) for vulvar High Grade Squamous Intraepithelial Lesion
排除标准
- •Prior HPV vaccination
- •(Micro-) invasive carcinoma or history of HPV related genital carcinoma (cervix, anal, vulva)
- •Women allergic to vaccine components
- •HIV infection
- •Immune compromised patients (currently on immunosuppressive medication)
结局指标
主要结局
Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between HPV vaccination and placebo up to 24 months post-treatment.
Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between HPV vaccination and placebo up to 24 months post-treatment.
次要结局
- Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between HPV vaccination and placebo at 6 and 12 months.
- Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between HPV vaccination and placebo at 6 and 12 months for primary vHSIL versus recurrent vHSIL.
- Difference in number and percentage of patients with clinical recurrence rate of vulvar HSIL between the different treatment modalities.
- Difference in number and percentage for additional treatment necessary after primary treatment.
- Description and percentage of different HPV types. Percentage clearance of primary HPV type for vaccination versus placebo.
- Number of HPV antibodies and percentage of increase or decrease after vaccination. Is there correlation between number or percentage of recurrence. Is that different in primary versus recurrent episode vHSIL.
- Incremental cost-effectiveness ratio (ICER), described the difference in costs and budget impact analysis.
- Description and change in numeric value and percentage in different score form questionnaires. Percentage increase of decrease quality of life, sexual impact and productivity impact.
- Difference number and percentage in HPV types cervical cytology and vHSIL before and after vaccination.
- Difference in number and percentage in recurrence rate of vulvar HSIL and vulvar cancer between HPV vaccination and placebo. Other HPV related disease known?
研究者
R.L.O van de Laar
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (33)
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