The Self-Sampling Pilot Study

Completed · Not applicable

Conditions studied: Squamous Cell Carcinoma of the Anus

In brief

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.

Key facts

Study ID

NCT07085845

Run by

Medical College of Wisconsin

People needed

50

Starts

2025-07-31

Expected to finish

2025-09-12

Last updated by the study team

2026-01-27

Who can join

Age: 35 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Presence of any contraindicating severe anal disease or condition, e.g., anal stenosis.

Where it is running

• Curative Building — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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