NCT07192055 Self-sampling to Optimize Anal Lesion Outcomes
| NCT ID | NCT07192055 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Anal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 572 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 572 participants in total. It began in 2025-11-18 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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.
Eligibility 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: 1. Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative. 2. Must be either: 1. A cisgender or transgender sexual minority man, or 2. A transgender woman who has sex with men. 3. Resides in Chicago, Houston, or Milwaukee metropolitan area. 4. Is willing to attend a study clinic. 5. Speak and understand either English or Spanish 6. 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. 1. Was a participant in the PAC Self-Swab Study in Milwaukee. 2. Currently on anticoagulants, with the exception of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, naproxen. 3. Diagnosed with hemophilia, cirrhosis with bleeding varices, or thrombocytopenia. 4. Presence of any contraindicating severe disease or condition, e.g., anal stenosis. 5. Plans to move within 12 months after enrollment.
Contact & Investigator
Alan Nyitray, PhD
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT07192055 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Anal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07192055 currently recruiting?
Yes, NCT07192055 is actively recruiting participants. Contact the research team at anyitray@mcw.edu for enrollment information.
Where is the NCT07192055 trial being conducted?
This trial is being conducted at Chicago, United States, Houston, United States, Milwaukee, United States.
Who is sponsoring the NCT07192055 clinical trial?
NCT07192055 is sponsored by Medical College of Wisconsin. The principal investigator is Alan Nyitray, PhD at Medical College of Wisconsin. The trial plans to enroll 572 participants.
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