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Could a simple Self-Swap replace the speculum for cervical cancer screening?

NCT ID NCT06611540

Diagnosis Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study compares self-collected vaginal samples to clinician-collected samples for HPV testing in 500 people referred for colposcopy. The goal is to see if self-collection is accurate enough to improve cervical cancer screening rates. Participants will provide both types of samples, and researchers will measure how well each detects precancerous changes.

What this could mean

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

Active substance
HPV Self-Collection
What this could lead to
If successful, this could make cervical cancer screening easier and more accessible by allowing people to collect their own samples at home.
What could go wrong
This is an early-stage study focused on accuracy, not on preventing cancer directly. Self-collection may be less sensitive than clinician-collected samples, and results may not apply 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 500 people

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

Started

Sep 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

25 years and older

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: * Willingness and ability to provide a documented informed consent. * Is 25 years or older. * Has an intact cervix. * Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance \[ASC-US\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit. * Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable. Exclusion Criteria: * Is pregnant when presenting for the referral visit or gave birth within the past 3 months. * Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit. * Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records. * Known medical conditions that, in the opinion of the investigator, preclude study participation. * Previous participation in the SHIP Trial. Participation is defined as completing the self-collection. * Is experiencing unusual bleeding or pelvic pain.

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Conditions

The condition(s) this trial relates to.

cervical carcinoma human papilloma virus infection Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical carcinoma Human papillomavirus infection

Contacts and locations

Locations

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245, United States

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