Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical, Vaginal and Vulvar Dysplasia and Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 409
- 试验地点
- 4
- 主要终点
- Sensitivity and specificity of anal pap testing to diagnose anal dysplasia
研究概览
简要总结
This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar cancer.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the prevalence of invasive squamous cell carcinoma of the anus in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
SECONDARY OBJECTIVES:
I. To estimate the prevalence of anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
EXPLORATORY OBJECTIVES:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically confirmed cervical, vaginal or vulvar high-grade dysplasia, invasive squamous cell carcinoma, invasive adenocarcinoma, or adenocarcinoma-in-situ (AIS). All stages and grades will be eligible.
- •Women with a diagnosis of high grade intraepithelial lesion (HSIL) from a routine pap test.
- •Patients must sign an approved informed consent document.
排除标准
- •Patients with previously documented perianal squamous cell dysplasia or invasive squamous cell carcinoma of the anus or anal canal.
- •Patients unwilling or unable to provide informed consent for the study.
- •Male patients will not be included in this study.
- •Patients with previously documented HPV related oropharyngeal cancer.
结局指标
主要结局
Sensitivity and specificity of anal pap testing to diagnose anal dysplasia
时间窗: Up to 5 years
Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.
Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia
时间窗: Up to 5 years
Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.
Prevalence of invasive squamous cell carcinoma of the anus
时间窗: Up to 5 years
Will estimate the prevalence of invasive squamous cell carcinoma of the anus in women with 95% confidence intervals.
Sensitivity and specificity of the combination of anal pap testing + anal HPV testing to diagnose anal dysplasia
时间窗: Up to 5 years
Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.
次要结局
未报告次要终点