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Self-sampling to Optimize Anal Lesion Outcomes

Medical College of Wisconsin · with National Cancer Institute (NCI), University of Chicago · NCT07192055

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 35+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
572
US sites recruiting
3
Study start
November 18, 2025
Record last updated
May 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of this research study is to find ways to increase anal cancer screening among people at increased risk for anal cancer. This study will try to find out if persons will do an intervention (self-sampling of the anal canal) and if it affects cytology and high-resolution anoscopy (HRA) appointment attendance. Secondarily, the study will assess if a person who gets their choice of either self-sampling or healthcare provider sampling affects clinic attendance.

Being studied: Self-sampling; Nylon-flocked Swab

Conditions: Anal Cancer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

A potential study subject who meets all of the following inclusion criteria is eligible to participate in the study. Note that these criteria apply regardless of HPV vaccination status or disability status.

Inclusion Criteria

  • Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.
  • Must be either:
  • A cisgender or transgender sexual minority man, or
  • A transgender woman who has sex with men.
  • Resides in Chicago, Houston, or Milwaukee metropolitan area.
  • Is willing to attend a study clinic.
  • Speak and understand either English or Spanish
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.

  • Was a participant in the PAC Self-Swab Study in Milwaukee.
  • Currently on anticoagulants, with the exception of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, naproxen.
  • Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia.
  • Presence of any contraindicating severe disease or condition, e.g., anal stenosis.
  • Plans to move within 12 months after enrollment.

Recruiting US locations

  • University of Chicago

    Chicago, IL 60637

    Site contact: Aniruddha Hazra, MD · 773-795-2016 · ahazra2@bsd.uchicago.edu

  • The University of Texas M.D. Anderson Cancer Center

    Houston, TX 77030

    Site contact: Craig Messick, MD · 713-745-1544

  • Medical College of Wisconsin

    Milwaukee, WI 53226

    Site contact: Alan Nyitray · 4149557701 · anyitray@mcw.edu

Study contacts (from the official record)

  • Alan G Nyitray, PhD · 4149557701 · anyitray@mcw.edu
  • Jenna Nitkowski, PhD · 414-955-2126 · jnitkowski@mcw.edu
All healthy volunteers studies in Illinois →
Self-sampling to Optimize Anal Lesion Outcomes (NCT07192055) | Bored Studies