New Strategies to Assess Anal Cancer Risk In Women

Completed

• Conditions: Human Immunodeficiency Virus (HIV); Human Papillomavirus (HPV)
• Interventions: Procedure: Perianal and Digital Anorectal Exam; Procedure: Cervical Swabs; Procedure: Anal Swabs; Procedure: High Resolution Anoscopy (HRA)

• Registration Number: NCT02873741
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-19
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation Study	High Resolution Anoscopy (HRA)	Participants will undergo a perianal and digital anorectal exam, a high resolution anoscopy, and cervical and anal swabs to determine the best method to identify women at high risk for anal cancer.
Validation Study	Cervical Swabs	Participants will undergo a perianal and digital anorectal exam, a high resolution anoscopy, and cervical and anal swabs to determine the best method to identify women at high risk for anal cancer.
Validation Study	Perianal and Digital Anorectal Exam	Participants will undergo a perianal and digital anorectal exam, a high resolution anoscopy, and cervical and anal swabs to determine the best method to identify women at high risk for anal cancer.
Validation Study	Anal Swabs	Participants will undergo a perianal and digital anorectal exam, a high resolution anoscopy, and cervical and anal swabs to determine the best method to identify women at high risk for anal cancer.

Primary Outcome Measures

Name	Time	Method
Anal Cancer Risk Index Score	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	Day 1	Assessment of high risk human papilloma virus in the anal cytology.

Trial Locations

Locations (1)

The Ponce Center; 🇺🇸 Atlanta, Georgia, United States