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临床试验/NCT00933140
NCT00933140已完成不适用

Anal HPV Infection and Abnormal Cytology in HIV-infected Women

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Primary objective is to determine the rate of anal cytologic and histologic abnormalities in HIV infected women at Boston Medical Center.

研究概览

简要总结

The population of HIV infected women seen at Boston Medical Center may have a higher frequency of anal cytologic and histologic abnormalities than what is reported for the non-HIV infected population.

详细描述

BACKROUND FOR THIS STUDY Anal cancer is a growing problem in the US. The incidence of anal cancer has increased among both men (160%) and women (78%) from 1973 to 2000 in the US [1]. In HIV-infected men the incidence of SCCA (squamous cell cancer of the anus) was found to range from 49-92 per 100,000 patient years [2]. This prompted recommendations on screening for anal cancer in this population. HIV-infected women are also at increased risk for developing anal cancer. A study based on data from AIDS and cancer registries found that the risk of anal cancer among women in the general population is about 1.2% and it increases up to 3.9% in the HIV-infected women. In addition, HIV-infected women had eight times the risk of in situ anal cancer compared with the number of expected cases [3].

SCCA appears to have many similarities to cervical cancers. HPV has been detected in 88% of anal cancer specimens with HPV-16 found in 73% of SCCA and HPV-18 in 7% [1]. In addition, SCCA develops in the transformation zone between the squamous epithelium of the anus and the columnar epithelium of the rectum, is frequently associated with dysplasia of the anus and may be preceded by squamous intraepithelial changes which are also associated with HPV.

Cervical cytology, also known as pap smear, can detect cervical cancer and its precursors. Countries who have adopted cervical cancer screening programs have had dramatic decreases in both the morbidity and mortality rates of cervical cancer.

Anal cytology may also be used to screen for HPV associated anal lesions, and among HIV-infected men who have sex with men, an abnormal cytology is frequently associated with a dysplastic squamous cell lesion of the anus. Anal HPV infections (high risk types) have been found in 53 ¿ 95% of HIV-infected men. Abnormal anal cytology has been found in 41-81% of HIV-infected men screened with high-grade cytologic findings in 2-25% of these patients [2].

There have been only a few studies looking at anal cytology in HIV-infected women. The largest study (n=235), by Holly and Palefsky [4], found that HIV positive women had a 26% prevalence of anal cytologic abnormalities (mostly atypical squamous cells of undetermined significance [ASCUS] and low grade squamous intraepithelial lesions [LSIL]). Forty-six of these women with abnormal cytology (60) underwent high resolution anoscopy (HRA) and 14 were found to have biopsy proven HSIL.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-64 years
  • HIV infected women
  • due for cervical cytologic screening

排除标准

  • Pregnancy
  • On chronic anticoagulation medication
  • Life expectancy of the woman is less than 1 year
  • If the woman has had a cervical or anal pap test in the last 6 months

结局指标

主要结局

Primary objective is to determine the rate of anal cytologic and histologic abnormalities in HIV infected women at Boston Medical Center.

时间窗: 2 years

次要结局

  • Identify risk factors for anal cytologic and histologic abnormalities in HIV infected women at BMC(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Stier

Attending and Associate Professor

Boston Medical Center

研究点 (1)

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