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)
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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