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NCT04423679 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by George Washington University.

Completed
Registry status
294
Enrollment target

NCT04423679 is a clinical trial that has completed, run by George Washington University. The registered enrollment target is 294 participants.

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The verdict

NCT04423679 has completed, sponsored by George Washington University.

COMPLETED
Registry status
294 participants
Enrollment target

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.

Interventions

  • DEVICE Evalyn Brush

Trial Details

FieldValue
Enrollment Target 294 participants
Start Date 2020-08-15
Est. Completion 2025-06-19

Sponsor

George Washington University

133 total trials

What the Registry Record Tells You About NCT04423679

The ClinicalTrials.gov registry entry for NCT04423679 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 294 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Evalyn Brush is the first listed.

NCT04423679 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04423679 about?

NCT04423679 is a clinical study titled "The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples". 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...

What is the current status of trial NCT04423679?

This trial is currently completed. The enrollment target is 294 participants. The study started on 2020-08-15. Estimated completion is 2025-06-19.

What interventions are being tested in trial NCT04423679?

The interventions under investigation include: Evalyn Brush (DEVICE).

Who is sponsoring clinical trial NCT04423679?

This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.