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New Strategies to Assess Anal Cancer Risk In Women (ANCAR-WIHS)

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Emory University

Status

Completed

Conditions

Human Immunodeficiency Virus (HIV)
Human Papillomavirus (HPV)

Treatments

Procedure: Cervical Swabs
Procedure: Anal Swabs
Procedure: Perianal and Digital Anorectal Exam
Procedure: High Resolution Anoscopy (HRA)

Study type

Observational

Funder types

Other

Identifiers

NCT02873741
IRB00083800
U01AI103408-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

143 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

143 participants in 1 patient group

Validation Study
Description:
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.
Treatment:
Procedure: Cervical Swabs
Procedure: High Resolution Anoscopy (HRA)
Procedure: Anal Swabs
Procedure: Perianal and Digital Anorectal Exam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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