New Strategies to Assess Anal Cancer Risk In Women
Completed
Conditions studied: Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV)
In brief
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.
Key facts
- Study ID
- NCT02873741
- Run by
- Emory University
- People needed
- 143
- Starts
- 2016-07-01
- Expected to finish
- 2017-02-27
- Last updated by the study team
- 2019-11-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- History of high grade anal intraepithelial neoplasia (AIN 2 or 3)
- History of active anal disease requiring surgery
- History of anal or cervical cancer
Where it is running
- The Ponce Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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