Status:

RECRUITING

Self-sampling to Optimize Anal Lesion Outcomes

Lead Sponsor:

Medical College of Wisconsin

Collaborating Sponsors:

National Cancer Institute (NCI)

University of Chicago

Conditions:

Anal Cancer

Eligibility:

All Genders

35+ years

Phase:

NA

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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.
  • 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

  • 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.

Key Trial Info

Start Date :

November 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2029

Estimated Enrollment :

572 Patients enrolled

Trial Details

Trial ID

NCT07192055

Start Date

November 1 2025

End Date

March 31 2029

Last Update

November 12 2025

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

University of Chicago

Chicago, Illinois, United States, 60637

2

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

3

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226