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RECRUITING
NCT07192055
NA

Self-sampling to Optimize Anal Lesion Outcomes

Sponsor: Medical College of Wisconsin

View on ClinicalTrials.gov

Summary

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.

Official title: Self-sampling to Optimize Anal Lesion Outcomes (SOLO)

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

INTERVENTIONAL

Enrollment

572

Start Date

2025-11-18

Completion Date

2029-03-31

Last Updated

2026-01-12

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

Self-sampling

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.

OTHER

Nylon-flocked Swab

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.

Locations (3)

University of Chicago

Chicago, Illinois, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States