Screening for Anal Cancer in Women with Prior HPV-Related Conditions

This study is looking at different ways to screen for anal cancer in women who have had certain HPV-related conditions (like cervical, vulvar, or vaginal pre-cancers or early cancers). Researchers want to see how well tests like anal cytology (a 'Pap test' for the anus) and HPV testing work to find early signs of anal cancer. They will also perform a digital rectal exam. You might be able to join if you are a woman aged 35 or older, have a history of high-grade HPV-related disease in your lower genital tract, and do not have HIV. The main goal is to find out how accurate these screening methods are. The study is currently unclear on its status and plans to enroll 300 participants.

Study design
This is a single-arm study, meaning all 300 participants will receive the same diagnostic tests. It is an interventional study, focusing on diagnostic tests for anal cancer screening.
What's involved
You would have an initial visit for diagnostic tests, including anal cytology, self-collected and clinician-collected HPV specimens, and a digital rectal exam. You would then have follow-up evaluations at 12 and 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after their initial evaluation.

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NCT05217940

Screening Women With Prior HPV for Anal Neoplasia

Recruiting
NAAges 35+InterventionalScreening
Icahn School of Medicine at Mount Sinai
~300 participants
Updated 2025-08-22 on ClinicalTrials.gov
What's tested:Diagnostic tests for anal cancer screening

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity of anal cytology
Measured over Baseline
HPV-related Lower Genital Tract Neoplasias
HPV-related Anal Neoplasias
Early Stage Lower Genital Tract Cancers
3 sites across 3 states
New York1
South Carolina1
Texas1
  • Keith Sigel, MD, PhD, MPH · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Elizabeth Chiao, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
  • Ashish Deshmukh, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

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Eligibility criteria

Inclusion

Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer)
Documented HIV seronegativity
Aged 35 years and older
Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston
English or Spanish speaking
  • Sensitivity and specificity of anal cytologyBaseline

    Test sensitivity and specificity