Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
研究概览
简要总结
Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.
Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age ≥ 40
- •Previous diagnosis of VIN 2/3 or vulvar
排除标准
- •Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer
- •Women who are HIV positive
- •Women currently taking immunosuppressant medication
- •Women who have had a previous hysterectomy
结局指标
主要结局
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
时间窗: 6 months to 1 year
次要结局
- Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN(6 months to 1 year)
- Prevalence of AIN in women with VIN 2/3 or vulvar cancer(6 months to 1 year)
研究者
Dr. Danielle Vicus
Dr. Danielle Vicus, MD, MSc, FRCSC
Sunnybrook Health Sciences Centre
