MedTrace Logo

Self-sampling to Optimize Anal Lesion Outcomes

NCT07192055 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2026-05-12

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Chicago

    collaborator OTHER

  • Froedtert Hospital

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Alan Nyitray, PhD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-18
Primary Completion
2028-03-31
Completion
2029-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07192055 on ClinicalTrials.gov