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Patient Self-sampling of HPV to Screen for Cervical Cancer

NCT05600283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2026-01-06

Study results available
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Summary

The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.

Conditions

Interventions

DIAGNOSTIC_TEST

Swab kit (COBAS HPV 4800 Assay -Evalyn brush)

Patient self-sampling swab kit to collect a vaginal sample for HPV testing

DIAGNOSTIC_TEST

Clinician-collection of cervical sample for HPV testing

Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)

Sponsors & Collaborators

Principal Investigators

  • Kathy MacLaughlin, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2024-06-04
Completion
2024-06-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05600283 on ClinicalTrials.gov