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Could a DIY swab replace the pelvic exam for cervical cancer screening?

NCT ID NCT06498661

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether women can collect their own vaginal samples for HPV testing as accurately as a doctor's sample. It involves 750 women referred for colposcopy or cervical procedures. The goal is to see if self-collection is a reliable alternative to traditional pelvic exams, which could make screening easier and more accessible.

What this could mean

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

Active substance
Self-collected vaginal sample for HPV testing
What this could lead to
If successful, this could make cervical cancer screening more accessible and comfortable, potentially increasing screening rates and catching pre-cancers earlier.
What could go wrong
This is an early-phase study focused on accuracy, not on long-term health outcomes. Self-collection may not be as sensitive as clinician collection, and results may vary by device or assay.

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 750 people

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

Started

Jun 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: * GROUP A: Willingness and ability to provide a documented informed consent * GROUP A: Is 25 years or older * GROUP A: Has an intact cervix * GROUP A: Has had a referral for colposcopy or cervical excisional procedure in which routine cervical cancer screening has included positive 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 * GROUP A: 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 * GROUP B: Willingness and ability to provide a documented informed consent * GROUP B: Is 25 years or older * GROUP B: Has an intact cervix * GROUP B: Eligible for regular cervical cancer screening by current national guidelines Exclusion Criteria: * GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months * GROUP A: 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 * GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records * GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation * GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months * GROUP A: Is experiencing unusual bleeding or pelvic pain * GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months * GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit * GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records * GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation * GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months * GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain * GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection

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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

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112, 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

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Puerto Rico

    San Juan, 00936, Puerto Rico

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298, United States

More trials for these conditions

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