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NCT04423679Completed

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

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
294 (actual)
First submitted
18 May 2020
Start date
15 Aug 2020
Primary completion date
24 Apr 2025
Lead sponsor
George Washington University
NCT number
NCT04423679

What you commit to

  • Study type: Observational
  • Participants enrolled: 294
  • From 15 Aug 2020 to the primary completion date, 24 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior hysterectomy

Other illness

  • History of Cervical Cancer

Other

  • Pregnancy
  • Inability to provide informed consent

Who the study is looking for

  • Female
  • Age 30-69
  • Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP)

Age in the registry: 30 years to 69 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Faculty Associates
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.