At a glance
ClinicalIndex Comparison Record- ✓Scheduled appointment at Mayo Clinic Rochester Gynecology Colposcopy Clinic or ICS Colposcopy Clinic (which includes speculum exam)
- ✓Scheduled appointment at Mayo Clinic Rochester Gynecology Clinic for indication requiring speculum exam (e.g., cervical cancer screening, IUD insertion)
- ✕Currently menstruating, pregnant, or within 3 months post-partum
- ✕History of total hysterectomy (no cervix)
- ✕Moderate to heavy vaginal bleeding on day of visit
- ✕Reason for visit is abnormal vaginal discharge
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening
In Brief
A clinical study evaluating Swab kit (COBAS HPV 4800 Assay -Evalyn brush) and Clinician-collection of cervical sample for HPV testing for Human Papilloma Virus. Completed, enrolled 222 participants across 1 site.
Detailed Summary
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.
Study Details
Timeline
Interventions
Patient self-sampling swab kit to collect a vaginal sample for HPV testing
Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)