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Can a simple HPV test replace colposcopy for cervical cancer Follow-Up?

NCT ID NCT01051895

Diagnosis Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to check for returning cervical pre-cancer after treatment: the standard colposcopy exam versus a high-risk HPV DNA test. Over 2,200 women who were treated for high-grade cervical lesions will be randomly assigned to one of the two follow-up methods. The goal is to see which approach is more sensitive at detecting persistent or recurrent disease, potentially making follow-up care simpler 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
high risk HPV DNA testing
What this could lead to
If successful, this could show that a simple HPV test is better than a colposcopy for catching returning cervical pre-cancer, potentially making follow-up easier and more accurate.
What could go wrong
This is a diagnostic comparison, not a treatment. The results may not change practice if HPV testing proves less effective or too costly. Also, the study is observational in nature, so it cannot prove that one strategy improves long-term health outcomes.

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

2,253 people

The number who actually took part.

Started

Jan 2010

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Ages

18 years and older

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: * Woman ≥ 18 years old 19 in British Columbia, Nova Scotia and Newfoundland) * Understands English or French (for sites where French speaking coordinator is available) * Is treated for biopsy proven CIN II, III or AIS * Understands study procedures, available alternatives treatment, risks related to study, and accepts voluntarily to participate by signing the ICF. Exclusion Criteria: * has been treated for cervical cancer or pre-cancer in the past * Participant has known immunosuppression or immunodeficiency * Planned hysterectomy * Participant is receiving or has received one of the following treatment : * Immunosuppressive therapy in the three months prior to enrollment * Corticosteroid therapy in the two weeks prior to enrollment * Two or more courses of corticosteroids (orally or parenterally) lasting at least one week in duration in the year prior to enrollment (inhalation, nasal or topical corticosteroids are permitted) * There is a strong probability that the participant will not follow the procedures of study, will not come to its appointment, or plans a delocalization throughout study.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma in situ cervical intraepithelial neoplasia cervical intraepithelial neoplasia grade 2/3 uterine cervix carcinoma in situ

As listed by the trial registrant

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

High grade cervical intra-epithelial neoplasia

Contacts and locations

Locations

  • Centre de recherche du CHUM

    Montreal, Quebec, H2X 0A9, Canada

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