Comparative Self-collection for Cervical Cancer Screening Pivotal Study
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
To evaluate whether individuals drawn from the intended use population can successfully interpret and follow the IFU for the Mia by XytoTest self-collection device and perform a vaginal sample collection yielding sufficient cellular material for primary hrHPV screening. To assess the clinical performance of Mia self-collected vaginal specimens by evaluating agreement with paired clinician-collected cervical specimens for the detection of high-risk HPV, when both specimen types are analyzed using the cobas HPV Test (Roche Molecular Systems). Residual samples may be used to determine adequacy for additional assays that require vaginal and/or cervical specimens (such as mRNA E6 and E7 Biomarker Test, dual stain cytology).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 25 do 65 lat
- •Chęć udziału w badaniu i zgoda na udział
- •Nieusunięta szyjka macicy
✗ Disqualifies
- •Brak zdolności do podejmowania decyzji lub wyrażenia świadomej zgody
- •Usunięcie całości lub części macicy, w tym szyjki macicy
- •Zabiegi na szyjce macicy w ciągu ostatnich 5 miesięcy
- •Ciąża
- •Menstruacja w dniu pobrania próbki
- •Krwawienie z pochwy w ciągu ostatnich 48 godzin
- •Kontakt seksualny, tampon lub produkty do higieny intymnej w ciągu ostatnich 48 godzin
- •Udział w innym badaniu klinicznym mogącym wpłynąć na wyniki
Simplified criteria — AI translation
Trial details
- Minimum age
- 25 Years
- Maximum age
- 65 Years
- Last updated (source)
- August 11, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (11)
ASR Arizona CGA
Phoenix, United States
Integrated Clinical Research
Sherman Oaks, United States
Altus Clinical Research
Lake Worth, United States
Zenacare Research
North Miami Beach, United States
ASR Idaho CGI
Boise, United States
Boeson Research - Great Falls
Great Falls, United States
Unified Women's Clinical Research
Raleigh, United States
Innovo-Wilmington Health
Wilmington, United States
Lyndhurst Clinical Research (Unified)
Winston-Salem, United States
El Centro de Corazon
Houston, United States
National Eagle Research
Lynnwood, United States
Trial contact
Liliana Montes
Rowena Schokman
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/12/2026.
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