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10-Year study checks if HPV test alone can replace pap smear

NCT ID NCT04185389

Knowledge-focused Sponsor: University of British Columbia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows over 1,700 women who previously took part in a cervical cancer screening trial. Researchers want to see if testing for HPV alone is as safe and effective as combining it with a Pap smear over 10 years. Participants provide a cervical sample for both tests, and the study tracks rates of abnormal cell changes. The goal is to improve screening guidelines and reduce unnecessary procedures.

What this could mean

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

What this could lead to
If successful, this could confirm that HPV testing alone is a safe and effective way to screen for cervical cancer, potentially simplifying screening guidelines.
What could go wrong
This is an observational follow-up study, not a new treatment trial. It cannot prove that HPV testing alone prevents cancer better than current methods, 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.

Participants

1,710 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2024

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

Study population consists entirely of participants from a previous RCT.

Ages

30 to 69 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Previous HPV FOCAL study, control arm participants who completed 48 month FOCAL LBC/HPV co-testing with no CIN2+ detected at trial exit * Resident of BC * \<69 years of age (upper age limit for routine screening per BC Cancer Cervix Screening program) * No history of CIN2+ since FOCAL study exit or in the last 5 years * Has not had a hysterectomy * Has never had a diagnosis of invasive cervical cancer

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Conditions

The condition(s) this trial relates to.

cervical cancer Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical cancer

Contacts and locations

Locations

  • Women's Health Research Institute

    Vancouver, British Columbia, V6H3N1, Canada

More trials for these conditions

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