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临床试验/NCT02873741
NCT02873741已完成不适用

New Strategies to Assess Anal Cancer Risk In Women

Emory University1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2016年7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
143
试验地点
1
主要终点
Anal Cancer Risk Index Score

研究概览

简要总结

The purpose of this research is to study different strategies to identify women at highest risk for anal cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk Index; it gives women an overall number score based on risk factors that they may have for anal cancer, such as age, number of sexual partners, or smoking. Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The study team will collect swabs of the cervix and the anus to study different laboratory tests that could identify women at highest risk of cervical and anal cancer. These laboratory tests include an anal pap smear, tests for markers of disease and tests that detect the HPV types most likely to cause cancer. The study team would like to see which of these laboratory tests do the best job at predicting precancerous lesions in the anus and are better indicators of risk for cancer. After collecting these swabs, women will have a procedure called high resolution anoscopy where investigators look closely at the anus and biopsy any suspicious areas. Finally, the study team will look for HPV proteins and changes that HPV can make in cells to see if these tests predict anal lesions.

详细描述

Investigators seek to study different strategies to identify women at highest risk for anal cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk Index; it gives women an overall number score based on risk factors that they may have for anal cancer, such as age, number of sexual partners, or smoking. The study team would like to determine whether women with higher Anal Cancer Risk Index scores are more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. Next, the team will collect a swab of the cervix and swabs of the anus to study different laboratory tests that could identify women at highest risk of anal cancer: these tests include an anal pap smear and tests that detect HPV types most likely to cause cancer. Investigators would like to see which of these laboratory tests do the best job at predicting precancerous lesions in the anus. After collecting these swabs, women will have a procedure called high resolution anoscopy where investigators will look closely at the anus and biopsy any suspicious areas. Finally, the study team will look for HPV proteins and changes that HPV can make in cells to see if these tests predict anal lesions. The HPV protein is called E6 and E7 and the cell change test is called CADM1/MAL/miR-124-2. Investigators will measure E6/E7 and CADM1/MAL/miR-124-2 in cervical and anal samples to see if women positive for this marker are more likely to have abnormal results on anal pap smears or anal biopsies.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Currently enrolled in the Women's HIV Interagency Study (WIHS) study
  • Able and willing to undergo anal cytology, anal molecular testing, and high resolution anoscopy with targeted anal biopsies

排除标准

  • History of high grade anal intraepithelial neoplasia (AIN 2 or 3)
  • History of active anal disease requiring surgery
  • History of anal or cervical cancer

结局指标

主要结局

Anal Cancer Risk Index Score

时间窗: Day 1

Assessment of anal cancer screening, risk factors for anal cancer, and its association with HPV using AIDS Risk Reduction Model Framework, that is a three stage model, including knowledge as a prerequisite to recognize risk and to take action to change or reduce the risk. Knowledge was measured with the Knowledge of Anal cancer and HPV, that is a 44-item knowledge multiple choice survey adapted from the Hild-Mosely, et al study, substituting "cervical" with "anal". A percentage score of correct responses was calculated and range from o to 100, being 100 the maximum correct result.

Presence of Anal hr-HPV

时间窗: Day 1

Assessment of high risk human papilloma virus in the anal cytology.

次要结局

未报告次要终点

研究者

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

Lisa Flowers

Professor

Emory University

研究点 (1)

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