Comparative Self-collection for Cervical Cancer Screening Pivotal Study
MIA-COMP
MIA-COMP Pivotal Study: COMParative Self-Collection for Cervical Cancer Screening
1 other identifier
interventional
260
1 country
11
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedFirst Submitted
Initial submission to the registry
August 6, 2026
CompletedFirst Posted
Study publicly available on registry
August 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedAugust 11, 2026
August 1, 2026
23 days
August 6, 2026
August 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of SAEs
Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection.
Between 6 and 14 days.
NPA and PPA
Concordance between self-collected and physician-collected samples.
Within one week of sample collection.
Study Arms (2)
General Population Group
ACTIVE COMPARATOR1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix.
Enriched Population Group
ACTIVE COMPARATOR1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix. 3. One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and/or presenting for colposcopy/LEEP/excisional intervention.
Interventions
Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens
Rovers Cervex-Brush is for physician collection of vaginal specimens.
Eligibility Criteria
You may qualify if:
- Group 1: General Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- Group 2: Enriched Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and/or presenting for colposcopy/LEEP/excisional intervention.
You may not qualify if:
- Apply to all groups:
- Impaired decision-making capacity or inability to provide informed consent.
- History of partial or total hysterectomy, including removal of the cervix.
- Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy).
- Current pregnancy (based on self-reporting).
- Active menstruation at time of specimen collection.
- Vaginal bleeding within 48 hours.
- Have had sex or used tampons, creams, or other vaginal products in the last 48 hours.
- Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study.
- Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mel Mont Medicallead
Study Sites (11)
ASR Arizona CGA
Phoenix, Arizona, 85004, United States
Integrated Clinical Research
Sherman Oaks, California, 91403, United States
Altus Clinical Research
Lake Worth, Florida, 33461, United States
Zenacare Research
North Miami Beach, Florida, 33169, United States
ASR Idaho CGI
Boise, Idaho, 83702, United States
Boeson Research - Great Falls
Great Falls, Montana, 59405, United States
Unified Women's Clinical Research
Raleigh, North Carolina, 27607, United States
Innovo-Wilmington Health
Wilmington, North Carolina, 28401, United States
Lyndhurst Clinical Research (Unified)
Winston-Salem, North Carolina, 27103, United States
El Centro de Corazon
Houston, Texas, 77012, United States
National Eagle Research
Lynnwood, Washington, 98036, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2026
First Posted
August 11, 2026
Study Start
July 9, 2026
Primary Completion
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
August 11, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share