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Could Self-Sampling revolutionize cervical cancer screening?

NCT ID NCT07758140

Diagnosis Sponsor: Mel Mont Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial evaluates whether a new self-collection device, Mia by XytoTest, can be used effectively by people to collect their own vaginal samples for cervical cancer screening. The study compares the accuracy of these self-collected samples against clinician-collected samples for detecting high-risk HPV, the virus that causes most cervical cancers. Participants include women aged 25 to 65 with an intact cervix, including those at higher risk due to prior abnormal results. If the device works well, it could offer a more private and convenient screening option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mia by XytoTest, a self-collection device for vaginal specimens
What this could lead to
If successful, this could enable at-home or clinic-based self-sampling for cervical cancer screening, making it more accessible and comfortable for many people.
What could go wrong
The trial is relatively small and focuses on agreement with clinician-collected samples, not long-term cancer outcomes. Self-collection may not always yield enough cells, and results may not generalize to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Group 1: General Population Group 1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix. Group 2: Enriched Population Group 1. 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. Exclusion Criteria: Apply to all groups: 1. Impaired decision-making capacity or inability to provide informed consent. 2. History of partial or total hysterectomy, including removal of the cervix. 3. Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy). 4. Current pregnancy (based on self-reporting). 5. Active menstruation at time of specimen collection. 6. Vaginal bleeding within 48 hours. 7. Have had sex or used tampons, creams, or other vaginal products in the last 48 hours. 8. Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study. 9. Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.

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Conditions

The condition(s) this trial relates to.

anogenital human papillomavirus infection human papilloma virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HPV HPV - anogenital human papilloma virus infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASR Arizona CGA

    RECRUITING

    Phoenix, Arizona, 85004, United States

  • ASR Idaho CGI

    RECRUITING

    Boise, Idaho, 83702, United States

  • Altus Clinical Research

    RECRUITING

    Lake Worth, Florida, 33461, United States

  • Boeson Research - Great Falls

    RECRUITING

    Great Falls, Montana, 59405, United States

  • El Centro de Corazon

    RECRUITING

    Houston, Texas, 77012, United States

  • Innovo-Wilmington Health

    RECRUITING

    Wilmington, North Carolina, 28401, United States

  • Integrated Clinical Research

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Lyndhurst Clinical Research (Unified)

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • National Eagle Research

    RECRUITING

    Lynnwood, Washington, 98036, United States

  • Unified Women's Clinical Research

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Zenacare Research

    RECRUITING

    North Miami Beach, Florida, 33169, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.