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
- Diseases
- Cervical cancer
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Faculty Associates Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.