Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Risk of anal dysplasia in women with cervical or vulvar dysplasia
研究概览
简要总结
This clinical trial studies colposcopy and high resolution anoscopy in screening for anal dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may help doctors find cancer cells early and plan better treatment for cancer
详细描述
OBJECTIVES:
I. To evaluate the risk of anal dysplasia in women with cervical or vulvar dysplasia.
OUTLINE:
Patients undergo colposcopy and cervical Papanicolaou test with Human papillomavirus (HPV) test followed by anal Papanicolaou test and high resolution anoscopy. Patients with dysplastic anal lesions undergo repeat anoscopy at 3, 9, 15, and 24 months. Patients with normal anoscopy are followed up at 1 and 2 years.
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
- •Histological confirmation of cervical, vaginal or vulvar intraepithelial neoplasia or cancer are included
- •Individuals treated with prior radiation therapy and/or chemotherapy are allowed
- •Women with high-grade dysplasia (carcinoma in situ) are eligible, regardless of their dysplasia free interval
- •HIV-positive (Human Immunodeficiency Virus) and HIV-negative women will be enrolled; HIV testing will not be performed as part of the study
排除标准
- •Women who are not able to consent are excluded
研究组 & 干预措施
Screening
See Detailed Description
干预措施: colposcopy (Procedure)
Screening
See Detailed Description
干预措施: cervical Papanicolaou test (Other)
Screening
See Detailed Description
干预措施: screening method (Procedure)
结局指标
主要结局
Risk of anal dysplasia in women with cervical or vulvar dysplasia
时间窗: Over 2 years
HPV (Human Papillomavirus) status
时间窗: Over 2 years
次要结局
未报告次要终点