Comparative Self-collection for Cervical Cancer Screening Pivotal Study
Public ClinicalTrials.gov record NCT07758140. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MIA-COMP Pivotal Study: COMParative Self-Collection for Cervical Cancer Screening
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT07758140
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 260 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 25 Years to 65 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 8, 2026
- Primary completion
- Jul 31, 2026
- Completion
- Aug 31, 2026
- Last update posted
- Aug 10, 2026
2026
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ASR Arizona CGA | Phoenix | Arizona | 85004 | Recruiting |
| Integrated Clinical Research | Sherman Oaks | California | 91403 | Recruiting |
| Altus Clinical Research | Lake Worth | Florida | 33461 | Recruiting |
| Zenacare Research | North Miami Beach | Florida | 33169 | Recruiting |
| ASR Idaho CGI | Boise | Idaho | 83702 | Recruiting |
| Boeson Research - Great Falls | Great Falls | Montana | 59405 | Recruiting |
| Unified Women's Clinical Research | Raleigh | North Carolina | 27607 | Recruiting |
| Innovo-Wilmington Health | Wilmington | North Carolina | 28401 | Recruiting |
| Lyndhurst Clinical Research (Unified) | Winston-Salem | North Carolina | 27103 | Recruiting |
| El Centro de Corazon | Houston | Texas | 77012 | Recruiting |
| National Eagle Research | Lynnwood | Washington | 98036 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07758140, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07758140 live on ClinicalTrials.gov.