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New Self-Test could revolutionize cervical cancer screening

NCT ID NCT04423679

Diagnosis Sponsor: George Washington University 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to screen for cervical cancer using samples women collect themselves at home. Researchers wanted to see if a test that looks at DNA changes in HPV could better identify who truly needs follow-up care. About 294 women participated, and the goal was to make screening easier and more accurate without needing a doctor visit.

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.

Participants

294 people

The number who actually took part.

Started

Aug 2020

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Women undergoing routine screening with Pap cytology and HPV testing or colposcopy at the George Washington University (GWU). From this population, a representative subset of 1000 women for self-sampling and methylation testing (400 cases and 600 controls). Most controls will come from the screening population, where we expect 85% to have negative HPV and cytology results. The majority of cases will come from the colposcopy referral population. Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in the case group (CIN2+); however, we will also perform sensitivity analyses excluding these women. Non-cases will include those with less than CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of negative screening).

Ages

30 to 69 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: * Female * Age 30-69 * Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP) Exclusion Criteria: * Pregnancy * History of Cervical Cancer * Prior hysterectomy * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical intraepithelial neoplasia grade 2/3 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 cancer Cin 2/3 Human papilloma virus

Contacts and locations

Locations

  • Medical Faculty Associates

    Washington D.C., District of Columbia, 20037, United States

More trials for these conditions

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