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Comparative Self-collection for Cervical Cancer Screening Pivotal Study

Mel Mont Medical · NCT07758140

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 25–65 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
260
US sites recruiting
11
Study start
July 9, 2026
Record last updated
August 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Mia by XytoTest; Rovers Cervex-Brush

Conditions: HPV; HPV - Anogenital Human Papilloma Virus Infection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Recruiting US locations

  • ASR Arizona CGA

    Phoenix, AZ 85004

    Site contact: Reena Grewal · 208-906-1600 · reena@idahoasr.com

  • Integrated Clinical Research

    Sherman Oaks, CA 91403

    Site contact: Iryna McCormick · 818-861-0088 · i.mccormick@icrsite.com

  • Altus Clinical Research

    Lake Worth, FL 33461

    Site contact: Stephanie Feliz · 561-641-0404 · sfeliz@altusresearch.com

  • Zenacare Research

    North Miami Beach, FL 33169

    Site contact: Paola Rothberg · 305-902-3135 · paola@zenacare.com

  • ASR Idaho CGI

    Boise, ID 83702

    Site contact: Stephanie Canning · 208-906-1600 · stephaniec@idahoasr.com

  • Boeson Research - Great Falls

    Great Falls, MT 59405

    Site contact: Katie Davis · 406-564-1775 · katie@boesonresearch.com

  • Unified Women's Clinical Research

    Raleigh, NC 27607

    Site contact: Cassie Harris · 919-788-4449 · cassie.harris@unifiedhc.com

  • Innovo-Wilmington Health

    Wilmington, NC 28401

    Site contact: Erin Funk · 910-362-4040 · rfunk@wilmingtonhealth.com

  • Lyndhurst Clinical Research (Unified)

    Winston-Salem, NC 27103

    Site contact: Amie Butler · 336-765-9350

  • El Centro de Corazon

    Houston, TX 77012

    Site contact: Amabely Hernandez · 832-488-8210 · ahernandez@clinicagenbio.com

  • National Eagle Research

    Lynnwood, WA 98036

    Site contact: Samiee Shokati · 206-775-0598 · sshokati@nationaleagleresearch.com

Study contacts (from the official record)

  • Liliana Montes · 305 335 6162 · l.montes@xytotest.com
  • Rowena Schokman · 301-641-3215 · rschokman@mdcassoc.com
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Comparative Self-collection for Cervical Cancer Screening Pivotal… (NCT07758140) | Bored Studies