Comparative Self-collection for Cervical Cancer Screening Pivotal Study (NCT07758140)
MIA-COMP Pivotal Study: COMParative Self-Collection for Cervical Cancer Screening
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: ASR Arizona CGA — Phoenix, Arizona
Age range: 25 Years to 65 Years
🧪 Interventions in This Study
- Mia by XytoTest (DIAGNOSTIC_TEST)
- Rovers Cervex-Brush (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- ASR Arizona CGA — Phoenix, Arizona
- Integrated Clinical Research — Sherman Oaks, California
- Altus Clinical Research — Lake Worth, Florida
- Zenacare Research — North Miami Beach, Florida
- ASR Idaho CGI — Boise, Idaho
- Boeson Research - Great Falls — Great Falls, Montana
- Unified Women's Clinical Research — Raleigh, North Carolina
- Innovo-Wilmington Health — Wilmington, North Carolina
- Lyndhurst Clinical Research (Unified) — Winston-Salem, North Carolina
- El Centro de Corazon — Houston, Texas
- National Eagle Research — Lynnwood, Washington
📞 Contact the Study Coordinator
Phone: (305) 335-6162
Email: l.montes@xytotest.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.