Anal CancerSOLONCT07192055
Self-sampling to Optimize Anal Lesion Outcomes
A study testing Self-sampling and Nylon-flocked Swab in people with Anal Cancer, run by Medical College of Wisconsin at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal Cancer
- What is being tested?
- Self-sampling and Nylon-flocked Swab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Nov 2025to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Aniruddha Hazra, MD, 773-795-2016, ahazra2@bsd.uchicago.edu
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Craig Messick, MD, 713-745-1544
cmessick@mdanderson.org
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Alan Nyitray, 4149557701, anyitray@mcw.edu
About this study
Official title: Self-sampling to Optimize Anal Lesion Outcomes (SOLO)
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.
- Conditions
- Anal Cancer
- Being tested
- Self-sampling, Nylon-flocked Swab
- Keywords
- anal cancer, human papillomavirus
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-samplingBehavioural
Also called self-collection
Self-sampling instructions will be provided to participants who will insert the swab into the anus to collect cells. Then the participant will put the swab in a vial of transport fluid for assessment at a laboratory.
Nylon-flocked SwabOther
At the cytology appointment, participants may receive self-sampling or clinician sampling with 1 of 2 kinds of swabs. The nylon-flocked swab is the intervention and will be assessed on patient acceptability and patient and clinician ability to collect an adequate sample.
| Study group | Role | What they receive |
|---|---|---|
| Self-sampling | Experimental | Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic. Receives: Other: Nylon-flocked Swab |
| Clinician sampling | Active comparator | A clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic. Receives: Behavioral: Self-sampling; Other: Nylon-flocked Swab |
| Nylon-flocked swab | Experimental | This is a swab with nylon-flocked material at the tip. Receives: Behavioral: Self-sampling |
| Dacron swab | Active comparator | This is a swab with a Dacron tip. Receives: Behavioral: Self-sampling; Other: Nylon-flocked Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the self-sampling intervention at cytology
Determine the number of individuals who attend the cytology appointment after exposure to the self-sampling intervention.
Measured: 1 month
Effect of self-sampling intervention at high-resolution anoscopy
Determine the number of individuals who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.
Measured: 2 months
Secondary outcomes (4)
Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV)
Determine the number of individuals with HIV who attend the cytology appointment after exposure to the self-sampling intervention.
Measured: 1 month
Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV
Determine the number of individuals with HIV who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.
Measured: 2 months
Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method
Assess the number of participants who attend their cytology appointment in the group randomized to their preferred sampling method.
Measured: 1 month
Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method
Assess the number of participants who attend their high-resolution anoscopy appointment in the group randomized to their preferred sampling method.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start18 Nov 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Chicago, Froedtert Hospital, M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Alan Nyitray, PhD, Medical College of Wisconsin
- Investigators
- Alan Nyitray, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192055
- Sponsor's protocol ID
- PRO00054186
- Other IDs
- R01CA298844
- Acronym
- SOLO
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-sampling to Optimize Anal Lesion Outcomes (SOLO)
- ClinicalTrials.gov ID
- NCT07192055
- Acronym / sponsor ID
- SOLO / PRO00054186
- Conditions
- Anal Cancer
- Keywords
- anal cancer, human papillomavirus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Chicago, Froedtert Hospital, M.D. Anderson Cancer Center
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Self-sampling | Experimental | Other: Nylon-flocked SwabParticipants will self-sample the anal canal with a swab. They will do this at home and at a clinic. |
| Clinician sampling | Active comparator | Behavioral: Self-sampling, Other: Nylon-flocked SwabA clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic. |
| Nylon-flocked swab | Experimental | Behavioral: Self-samplingThis is a swab with nylon-flocked material at the tip. |
| Dacron swab | Active comparator | Behavioral: Self-sampling, Other: Nylon-flocked SwabThis is a swab with a Dacron tip. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 35 years for those who are HIV-positive or ≥ 45 years for those who are HIV-negative.
- Must be either:
- Resides in Chicago, Houston, or Milwaukee metropolitan area.
- Is willing to attend a study clinic.
- Speak and understand either English or Spanish
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-samplingAlso: self-collectionSelf-sampling instructions will be provided to participants who will insert the swab into the anus to collect cells. Then the participant will put the swab in a vial of transport fluid for assessment at a laboratory. | Behavioural | Clinician sampling, Dacron swab, Nylon-flocked swab |
| Nylon-flocked SwabAt the cytology appointment, participants may receive self-sampling or clinician sampling with 1 of 2 kinds of swabs. The nylon-flocked swab is the intervention and will be assessed on patient acceptability and patient and clinician ability to collect an adequate sample. | Other | Clinician sampling, Dacron swab, Self-sampling |
Primary outcome
Effect of the self-sampling intervention at cytology
Time frame: 1 month
Determine the number of individuals who attend the cytology appointment after exposure to the self-sampling intervention.
Effect of self-sampling intervention at high-resolution anoscopy
Time frame: 2 months
Determine the number of individuals who attend the high-resolution anoscopy appointment after exposure to the self-sampling intervention.
4 secondary outcomes
Effect of the self-sampling intervention at cytology on people with human immunodeficiency virus (HIV)
Time frame: 1 month
Effect of the self-sampling intervention at high-resolution anoscopy on people with HIV
Time frame: 2 months
Effect of the self-sampling intervention at cytology on people randomized to their preferred sampling method
Time frame: 1 month
Effect of the self-sampling intervention at high-resolution anoscopy on people randomized to their preferred sampling method
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Yes. Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Nyitray, PhD principal investigator
Medical College of Wisconsin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-sampling and Nylon-flocked Swab in people with Anal Cancer, run by Medical College of Wisconsin at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan G Nyitray, PhD (4149557701, anyitray@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the self-sampling intervention at cytology (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.