The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Sensitivity and specificity of anal cytology
研究概览
简要总结
The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.
详细描述
This single arm trial will enroll 300 HIV uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, HPV testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. Participants will undergo evaluation at baseline and then at 12 and 24 months. The investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. The trial is expected to run from 2021-2027.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer)
- •Documented HIV seronegativity
- •Aged 35 years and older
- •Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston
- •English or Spanish speaking
排除标准
- •prior history or high resolution anoscopy
结局指标
主要结局
Sensitivity and specificity of anal cytology
时间窗: Baseline
Test sensitivity and specificity
次要结局
- Concordance of self- and clinician-collected PCR testing(baseline)
- Prevalence of hrHPV types at baseline(Baseline)
- hrHPV with Cobas PCR testing (self-collected)(24 months)
- Incidence of aHSIL at follow-up(24 months)
- Proportion of subjects with new hrHPV infection(24 months)
- hrHPV with Cobas PCR testing (clinician-collected)(24 months)
- Screening Experience Survey(Baseline)
- Incidence of hrHPV, by type(24 months)
- Prevalence of aHSIL at baseline(Baseline)
研究者
Keith M Sigel
Associate Professor
Icahn School of Medicine at Mount Sinai