Clinical trial · Observational
The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
| Human Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evalyn Brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CIN2+
- description
- 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.
- interventionNames
- Device: Evalyn Brush
- label
- < CIN2
- description
- 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).
- interventionNames
- Device: Evalyn Brush
Primary outcomes (3)
- measure
- Evaluating the relative sensitivity and specificity of HPV methylation testing from collected samples
- timeFrame
- Up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age 30-69 * Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP) Exclusion Criteria: * Pregnancy * History of Cervical Cancer * Prior hysterectomy * Inability to provide informed consent
References
Publications (0)
Data not yet available