An interventional study of Self-sampling and Nylon-flocked Swab in Anal Cancer, sponsored by Medical College of Wisconsin. Recruiting at 3 sites in United States. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Prevention
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.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 572 is above the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Must be either:
Exclusion Criteria:
A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will self-sample the anal canal with a swab. They will do this at home and at a clinic.
Other: Nylon-flocked Swab
A clinician will collect a sample from the anal canal of the participant with a swab. They will do this at the clinic.
Behavioral: Self-sampling · Other: Nylon-flocked Swab
This is a swab with nylon-flocked material at the tip.
Behavioral: Self-sampling
This is a swab with a Dacron tip.
Behavioral: Self-sampling · Other: Nylon-flocked Swab
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.
Also known as: self-collection
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.
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.
Time frame: 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.
Time frame: 2 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 months
Effect of the self-sampling intervention among Black individuals at cytology
Determine the number of Black individuals who attend the cytology appointment after exposure to the self-sampling intervention.
Time frame: 1 month
Effect of the self-sampling intervention among Black individuals at high-resolution anoscopy
Determine the number of Black individuals who attend high-resolution anoscopy appointments after exposure to the self-sampling intervention.
Time frame: 2 months
Assess the adequacy of nylon-flocked swabs
Determine the number of nylon-flocked swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3).
Time frame: 1 month
Assess the adequacy of Dacron swabs
Determine the number of Dacron swabs that are cytologically adequate (defined as 2000-3000 nucleated squamous cells/mm3).
Time frame: 1 month
Assess participant pain after using the nylon-flocked swab
The Wong-Baker FACES® Pain Rating Scale measures the severity of pain, if any. Possible scores range from 0 to 10 with higher scores indicating increased severity of pain.
Time frame: 1 month
Assess participant pain after using the Dacron swab
The Wong-Baker FACES® Pain Rating Scale measures the severity of pain, if any. Possible scores range from 0 to 10 with higher scores indicating increased severity of pain.
Time frame: 1 month
Assess participant comfort after using the nylon-flocked swab
The variable comfort measures the individual's reported comfort on a 4-point Likert scale from Strongly Agree to Strongly Disagree. Possible scores range from 1 to 4 with higher scores indicating decreased comfort after using the nylon-flocked swab.
Time frame: 1 month
Assess participant comfort after using the Dacron swab
The variable comfort measures the individual's reported comfort on a 4-point Likert scale from Strongly Agree to Strongly Disagree. Possible scores range from 1 to 4 with higher scores indicating decreased comfort after using the Dacron swab
Time frame: 1 month
Plan to share: 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.
Time frame: Data will become available one year after study completion.
Access criteria: 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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