New Strategies to Assess Anal Cancer Risk In Women

Human Immunodeficiency Virus (HIV) Clinical Trial

— ANCAR-WIHS  

Official title:

New Strategies to Assess Anal Cancer Risk In Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873741
• Other study ID #: IRB00083800
• Secondary ID: U01AI103408-03
• Status: Completed
• Start date: July 2016
• Est. completion date: February 27, 2017

Study information

• Verified date: November 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Anus Neoplasms
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Human Papillomavirus (HPV)

Intervention

Procedure:
• Perianal and Digital Anorectal Exam
The physician will inspect the outside of the anus and use a gloved finger to feel the anus for any masses.
• Cervical Swabs
A speculum will be inserted into the vagina to visualize the cervix. The sample for research tests will be collected with one ThinPrep cytobroom inserted into the cervix. Collection will be same for the sample to be paced in the RNA storage solution for future biomarker studies.
• Anal Swabs
The anal cytology specimen will be collected by inserting a saline moistened cotton-tipped swab into the anus, rotating it clock-wise for 20 seconds, and placed in SurePath. The first twenty participants will have anal cells collected in two different ways for validation/optimization: 1) saline moistened Dacron swab placed directly in ThinPrep medium and 2) Medscand Cytobrush Plus, a special brush, placed directly into ThinPrep medium. After validation/optimization is complete for up to 20 participants, the best collection method will be selected and will be used for all future enrolled participants.
• High Resolution Anoscopy (HRA)
High Resolution Anoscopy is a procedure that allows for examination and evaluation of the anal canal. Using a small thin round tube called an anoscope, the anal canal is examined with a high resolution magnifying instrument called a colposcope. Application of a mild acidic liquid (acetic acid or diluted vinegar) or a brown iodine-based solution (Lugol's) onto the anal canal facilitates evaluation of abnormal tissue such as anal dysplasia. If abnormal staining is seen using acetic acid (dense white lesion) or Lugol's solution (bright yellow lesion) a biopsy of that area will be obtained.

Locations

Country	Name	City	State
United States	The Ponce Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lahiri CD, Nguyen ML, Mehta CC, Mosunjac M, Tadros T, Unger ER, Rajeevan MS, Richards J, Ofotokun I, Flowers L. Pilot study of markers for high-grade anal dysplasia in a southern cohort from the Women's Interagency HIV Study (WIHS). Clin Infect Dis. 2019 May 6. pii: ciz336. doi: 10.1093/cid/ciz336. [Epub ahead of print] — View Citation

Wells JS, Flowers L, Paul S, Nguyen ML, Sharma A, Holstad M. Knowledge of Anal Cancer, Anal Cancer Screening, and HPV in HIV-Positive and High-Risk HIV-Negative Women. J Cancer Educ. 2019 Mar 8. doi: 10.1007/s13187-019-01503-8. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal Cancer Risk Index Score	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.	Day 1
Primary	Presence of Anal hr-HPV	Assessment of high risk human papilloma virus in the anal cytology.	Day 1