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The Self-Sampling Pilot Study

NCT07085845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-27

Study results available
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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.

Conditions

  • Squamous Cell Carcinoma of the Anus

Interventions

OTHER

Inserting a swab 5 cm into the anus during self-sampling

The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 5 cm to collect anal exfoliated cells.

OTHER

Self-sampling with a swab by inserting the swab 3 cm into the anus.

The swab will be inserted into the anus by the lay individual. The individual will insert the swab to a depth of 3 cm to collect anal exfoliated cells.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Alan Nyitray, PhD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2025-09-12
Completion
2025-09-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085845 on ClinicalTrials.gov