Human Papilloma VirusSELFIENCT04423679
The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples
An observational study of Human Papilloma Virus and Cervical Cancer, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Cervical Cancer, CIN 2/3
- What is being tested?
- Evalyn Brush
- Type of treatment
- Medical device
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to 19 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women undergoing routine screening with Pap cytology and HPV testing or colposcopy at the George Washington University (GWU). From this population, a representative subset of 1000 women for self-sampling and methylation testing (400 cases and 600 controls). Most controls will come from the screening population, where we expect 85% to have negative HPV and cytology results. The majority of cases will come from the colposcopy referral population. Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in the case group (CIN2+); however, we will also perform sensitivity analyses excluding these women. Non-cases will include those with less than CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of negative screening).
Who may be able to join
- Female
- Age 30-69
- Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP)
Who cannot join
- Pregnancy
- History of Cervical Cancer
- Prior hysterectomy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
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.
Read the detailed description
Worldwide, cervical cancer remains the fourth most common cancer and fourth leading cause of cancer deaths among women, with the greatest burden occurring in low-resource settings that lack effective screening and treatment. Even in the United States (U.S.), where Pap cytology screening has resulted in dramatic declines in cervical cancer incidence and mortality, thousands of new cases and related-deaths still occur every year, most commonly among underserved women who face barriers to accessing screening and/or treatment. The recent implementation of human papillomavirus (HPV) DNA testing as a primary strategy for cervical cancer screening has the potential to alleviate these disparities by improving the sensitivity for cervical precancer detection compared to Pap cytology, while providing greater long term reassurance following a negative HPV test. Moreover, HPV testing can be successfully performed on self-collected specimens, offering the possibility of expanding access to cervical cancer screening among hard-to-reach, underserved women.
Despite the many advantages of primary HPV screening, the current challenge is optimizing triage testing to determine who among the many women testing HPV positive are at high-risk and require immediate colposcopy referral or treatment, while avoiding unnecessary harms among women at low-risk. A molecular triage test that can be conducted from the same primary screening sample (i.e., reflex testing) is particularly attractive for both high-and low-resource settings, particularly if it works from self-collected samples. Previously, DNA methylation of candidate host cell genes has been evaluated in self-collected samples and achieved acceptable performance for triage of HPV-positive women. In studies using clinician collected samples, there is a suggestion that methylation of carcinogenic HPV genotypes has better clinical performance (higher sensitivity/specificity) compared to host gene methylation; however, HPV methylation has not been evaluated in self-collected specimens. Because HPV DNA is present in only a small subset of infected cells in the lower genital tract, particularly in cervical precancers, it is likely that the signal-to noise ratio in self-collected samples is better for HPV compared to host gene methylation, resulting in improved specificity for cervical precancer detection. Evaluating the feasibility of HPV DNA methylation testing from self-collected samples is essential for determining the extent to which this assay can address the critical need for HPV triage in high- and low resource settings. In collaboration with the Cancer Genome Research Laboratory, a high-throughput, low-cost next-generation bisulfite sequencing assay that detects methylation of the 12 most carcinogenic HPV genotypes has been developed. Further, this assay includes a panel of host genes, including those that have been previously evaluated in self-collected specimens. The proposal is to test this assay in paired self and clinician-collected samples from 1,000 women enrolled in an ongoing prospective study of women undergoing cervical cancer screening and colposcopy at the George Washington University (GWU). The hypothesis is that HPV and host DNA methylation will show non-inferior sensitivity and specificity for detection of cervical precancer in self-collected compared to clinician-collected samples and that HPV methylation will have higher absolute specificity compared to host methylation in both sample types.
- Conditions
- Human Papilloma Virus, Cervical Cancer, CIN 2/3
- Being tested
- Evalyn Brush
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evalyn BrushDevice
a standard brush-based cervicovaginal self-collection device
| Study group | Role | What they receive |
|---|---|---|
| CIN2+ | Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in this group. Receives: Device: Evalyn Brush | |
| < CIN2 | Non-cases will include those with <CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of a negative screening test). Receives: Device: Evalyn Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the relative sensitivity and specificity of HPV methylation testing from collected samples
Evaluate the relative sensitivity and specificity of HPV methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.
Measured: Up to 24 months
Evaluating the relative sensitivity and specificity of host gene methylation testing from collected samples
Evaluate the relative sensitivity and specificity of host gene methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.
Measured: Up to 24 months
Comparing the absolute sensitivity and specificity of HPV versus host gene methylation testing
Compare the absolute sensitivity and specificity of HPV versus host gene methylation testing for the detection of cervical pre-cancer in both self-collected and clinician-collected samples
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Aug 2020
- Primary completion24 Apr 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Sarasota Memorial Health Care System
- Responsible party
- Principal investigator, Richard Lush, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423679
- Sponsor's protocol ID
- NCR191015
- Acronym
- SELFIE
- Status last verified
- Mar 2026
- First submitted
- 18 May 2020
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples
- ClinicalTrials.gov ID
- NCT04423679
- Acronym / sponsor ID
- SELFIE / NCR191015
- Conditions
- Human Papilloma Virus, Cervical Cancer, CIN 2/3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Sarasota Memorial Health Care System
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Worldwide, cervical cancer remains the fourth most common cancer and fourth leading cause of cancer deaths among women, with the greatest burden occurring in low-resource settings that lack effective screening and treatment. Even in the United States (U.S.), where Pap cytology screening has resulted in dramatic declines in cervical cancer incidence and mortality, thousands of new cases and related-deaths still occur every year, most commonly among underserved women who face barriers to accessing screening and/or treatment. The recent implementation of human papillomavirus (HPV) DNA testing as a primary strategy for cervical cancer screening has the potential to alleviate these disparities by improving the sensitivity for cervical precancer detection compared to Pap cytology, while providing greater long term reassurance following a negative HPV test. Moreover, HPV testing can be successfully performed on self-collected specimens, offering the possibility of expanding access to cervical cancer screening among hard-to-reach, underserved women.
Despite the many advantages of primary HPV screening, the current challenge is optimizing triage testing to determine who among the many women testing HPV positive are at high-risk and require immediate colposcopy referral or treatment, while avoiding unnecessary harms among women at low-risk. A molecular triage test that can be conducted from the same primary screening sample (i.e., reflex testing) is particularly attractive for both high-and low-resource settings, particularly if it works from self-collected samples. Previously, DNA methylation of candidate host cell genes has been evaluated in self-collected samples and achieved acceptable performance for triage of HPV-positive women. In studies using clinician collected samples, there is a suggestion that methylation of carcinogenic HPV genotypes has better clinical performance (higher sensitivity/specificity) compared to host gene methylation; however, HPV methylation has not been evaluated in self-collected specimens. Because HPV DNA is present in only a small subset of infected cells in the lower genital tract, particularly in cervical precancers, it is likely that the signal-to noise ratio in self-collected samples is better for HPV compared to host gene methylation, resulting in improved specificity for cervical precancer detection. Evaluating the feasibility of HPV DNA methylation testing from self-collected samples is essential for determining the extent to which this assay can address the critical need for HPV triage in high- and low resource settings. In collaboration with the Cancer Genome Research Laboratory, a high-throughput, low-cost next-generation bisulfite sequencing assay that detects methylation of the 12 most carcinogenic HPV genotypes has been developed. Further, this assay includes a panel of host genes, including those that have been previously evaluated in self-collected specimens. The proposal is to test this assay in paired self and clinician-collected samples from 1,000 women enrolled in an ongoing prospective study of women undergoing cervical cancer screening and colposcopy at the George Washington University (GWU). The hypothesis is that HPV and host DNA methylation will show non-inferior sensitivity and specificity for detection of cervical precancer in self-collected compared to clinician-collected samples and that HPV methylation will have higher absolute specificity compared to host methylation in both sample types.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIN2+ | – | Device: Evalyn BrushCases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in this group. |
| < CIN2 | – | Device: Evalyn BrushNon-cases will include those with <CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of a negative screening test). |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing routine screening with Pap cytology and HPV testing or colposcopy at the George Washington University (GWU). From this population, a representative subset of 1000 women for self-sampling and methylation testing (400 cases and 600 controls). Most controls will come from the screening population, where we expect 85% to have negative HPV and cytology results. The majority of cases will come from the colposcopy referral population. Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in the case group (CIN2+); however, we will also perform sensitivity analyses excluding these women. Non-cases will include those with less than CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of negative screening).
Key inclusion criteria (3 listed)
- Female
- Age 30-69
- Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP)
Key exclusion criteria (4 listed)
- Pregnancy
- History of Cervical Cancer
- Prior hysterectomy
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evalyn Brusha standard brush-based cervicovaginal self-collection device | Device | < CIN2, CIN2+ |
Primary outcome
Evaluating the relative sensitivity and specificity of HPV methylation testing from collected samples
Time frame: Up to 24 months
Evaluate the relative sensitivity and specificity of HPV methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.
Evaluating the relative sensitivity and specificity of host gene methylation testing from collected samples
Time frame: Up to 24 months
Evaluate the relative sensitivity and specificity of host gene methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.
Comparing the absolute sensitivity and specificity of HPV versus host gene methylation testing
Time frame: Up to 24 months
Compare the absolute sensitivity and specificity of HPV versus host gene methylation testing for the detection of cervical pre-cancer in both self-collected and clinician-collected samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Human Papilloma Virus
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus and Cervical Cancer, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the relative sensitivity and specificity of HPV methylation testing from collected samples (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.