Clinical Trial

The Self-Sampling Pilot Study

Study acronym: SOLOPilot
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-07-18; most recent amendment 2026-01-26.
Status change: Recruiting → Completed 2025-09-18
Status change: Not Yet Recruiting → Recruiting 2025-08-26
Trial Details
NCT Number NCT07085845
Lead Sponsor Medical College of Wisconsin
Conditions Squamous Cell Carcinoma of the Anus
Enrollment 50 participants
Start Date 2025-07-31
Primary Completion 2025-09-12 (estimated)
Study Completion 2025-09-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-27