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The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples

NCT04423679 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 294

Last updated 2026-03-06

No results posted yet for this study

Summary

Cervical cancer is primarily caused by Human Papillomaviruses (HPV). Testing for HPV in cervical samples is now an option for cervical cancer screening. HPV can also be tested from self-collected samples which may help to improve access to screening, since it does not require a doctor visit. However, many women will test positive for HPV who are not at high risk for cervical cancer. Therefore, additional ("triage") tests are needed to determine which women testing HPV-positive require additional clinical workup. For self sampling, a triage test that could be measured from the same initial sample without requiring a follow-up visit to the doctor would be an ideal strategy. The purpose of this study is to determine whether a new HPV test that measures changes in HPV DNA can be used to triage HPV-positive women using self collected samples. This study will enroll 1,000 women who are undergoing cervical cancer screening at the George Washington University. Women will be asked to take a self-collected sample prior to their clinic visit. The investigators will evaluate the clinical accuracy of the new HPV triage test in self-collected samples and compare the accuracy of the test in samples collected by the clinician.

Conditions

Interventions

DEVICE

Evalyn Brush

a standard brush-based cervicovaginal self-collection device

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sarasota Memorial Health Care System

    collaborator OTHER

  • George Washington University

    lead OTHER

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2025-04-24
Completion
2025-06-19

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 NCT04423679 on ClinicalTrials.gov