Assessing new markers for cervical cancer screening using self-collected samples
The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples
George Washington University · NCT04423679
This study is testing a new HPV test that women can use at home to see if they need more check-ups for cervical cancer after testing positive for HPV.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 30 Years to 69 Years |
| Sex | Female |
| Sponsor | George Washington University (other) |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT04423679 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a novel HPV test that measures changes in HPV DNA to triage women who test positive for HPV using self-collected samples. By enrolling 1,000 women undergoing cervical cancer screening at George Washington University, the study seeks to improve access to screening, particularly for underserved populations. The goal is to determine if this new triage test can effectively identify which HPV-positive women require further clinical evaluation without the need for a follow-up doctor visit.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30-69 who are undergoing cervical cancer screening or related procedures.
Not a fit: Patients who are pregnant, have a history of cervical cancer, or have had a prior hysterectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cervical cancer screening accessibility and reduce unnecessary medical interventions for low-risk women.
How similar studies have performed: Other studies have shown promise in using self-collected samples for HPV testing, indicating that this approach is both innovative and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington, District of Columbia
- Medical Faculty Associates — Washington, District of Columbia, United States (RECRUITING)
Study contacts
- Study coordinator: Nicole Chappell, MD
- Email: nChappell@mfa.gwu.edu
- Phone: 202 741 2434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Human Papilloma Virus, Cervical Cancer, CIN 2/3