N/A
N=50
The Self-Sampling Pilot Study
Squamous Cell Carcinoma of the Anus
Bottom Line
View on ClinicalTrials.gov: NCT07085845 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Presence of Squamocolumnar Cells — 11; 8; 12; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inserting a swab 5 cm into the anus during self-sampling (Other); Self-sampling with a swab by inserting the swab 3 cm into the anus. (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Male
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Sep 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Squamocolumnar Cells |
11; 8; 12; 19 | — |
| SECONDARY Cytologic Adequacy |
20; 19; 3; 8 | — |
| SECONDARY User Acceptability of New NF Swab Compared to Swab From Prior Research |
13; 21; 10; 6; 0; 0 | 0.99 |
| SECONDARY User Pain of New NF Swab Compared to Swab From Prior Research |
12; 15; 9; 10; 1; 1 | 0.47 |
| SECONDARY User Pain by Swab Length |
12; 15; 9; 10; 1; 1 | — |
Summary
The investigators will test the cytological performance of a nylon-flocked swab at two insertion depths in the anus, 3 cm and 5 cm, to determine which insertion depth is better at collecting cells from the squamocolumnar junction (SCJ), an anatomic site that is particularly vulnerable to carcinogenic transformation. The investigators hypothesize that the 5 cm insertion will result in a higher quality specimen with cells from the SCJ. However, the deeper swab insertion may affect end user acceptability without increasing adequacy or quality.
Eligibility Criteria
Inclusion Criteria
- Aged ≥ 35 years.
- Must be either:
- A sexual minority man, or
- A woman who has a different identity than the sex she was born with.
- Resides in the Milwaukee metropolitan area.
- Speak and understand English.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
- Presence of any contraindicating severe anal disease or condition, e.g., anal stenosis.
Data sourced from ClinicalTrials.gov (NCT07085845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.