Active not recruitingNAINTERVENTIONAL

Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers

This research is looking for the best way to follow up with women who have been treated for high-grade cervical precancer (serious cell changes that could lead to cancer if untreated). Currently, women have regular colposcopy check-ups. This study wants to see if HPV testing, which looks for the human papillomavirus that causes these changes, could be a better way to find if the precancer has returned or wasn’t fully removed. Women taking part will be randomly assigned to either receive HPV tests or continue with routine colposcopy after their treatment. Over two years, researchers will compare which method is more effective at spotting any new or remaining precancerous cells. The goal is to improve how we monitor women, ensuring any issues are caught quickly.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

2,253

Start

01 Jan 2010

Estimated completion

01 Dec 2027

High Grade Cervical Intra-epithelial Neoplasia

What is this study about?

This study is all about finding the best way to look after women who have had treatment for serious changes in their cervix. These changes, often called 'precancerous cells' or 'high-grade cervical intra-epithelial neoplasia (CIN)', are not cancer yet, but they could turn into cancer if not treated. The good news is they can often be removed successfully.

After treatment, it's really important to make sure all the abnormal cells are gone and don't come back. Currently, in many places, women have regular check-ups called colposcopies. This is where a doctor uses a special magnifying tool to look closely at the cervix. However, some research suggests that colposcopies might not always catch everything.

This study wants to compare the usual colposcopy check-ups with a different test called HPV testing. HPV stands for Human Papillomavirus, which is a common virus that causes these cervical cell changes. An HPV test simply checks for the presence of this virus in your cervical cells. The main question this research aims to answer is: Is HPV testing better than routine colposcopy at finding any remaining or returning serious precancerous cells after treatment? The findings could help doctors decide the best way to monitor women in the future, making sure any new problems are found quickly.

Key takeaways

Compares HPV testing vs. routine colposcopy for follow-up.
Aims to find the best way to check for returning precancerous cells after treatment.
Participation involves yearly check-ups for two years.
Results could improve future care for women treated for cervical precancer.
You will be offered re-treatment if any problems are found.

Who may be eligible?

To be able to take part in this study, you need to be a woman who is at least 18 years old.

You must have recently been treated for serious changes in your cervix, specifically those confirmed by a biopsy as CIN II, CIN III, or AIS (Adenocarcinoma in situ). You also need to understand the study procedures, any other treatment options available, and the potential risks involved, and be willing to sign a consent form to participate.

There are also some reasons why you wouldn't be able to join. For example, if you've already been treated for cervical cancer or precancer before, or if your immune system is weakened. The study also isn't suitable if you're planning to have your womb removed (a hysterectomy), or if you've recently taken certain medications like strong immunosuppressants or corticosteroids. Finally, you need to be able to attend all appointments throughout the study and not be planning to move away.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or over?
Have you recently been treated for serious cervical cell changes (CIN II, CIN III, or AIS)?
Do you understand the study and agree to take part?
Have you *not* been treated for cervical cancer or precancer before?
Are you able to attend all study appointments over the next two years?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll first be randomly assigned to one of two groups – like drawing lots. One group will have routine colposcopy check-ups, and the other group will have HPV tests instead. This is done by chance to make the comparison fair.

Over the next two years after your treatment for cervical precancer, you will have yearly, thorough check-ups of your cervix. The type of check-up will depend on which group you're in. If any problems are found through either method, you'll be offered further treatment straight away. The total duration of your active participation, including these check-ups, will be two years.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as potentially helping to identify any remaining precancerous cells earlier, depending on which follow-up method proves more effective. You'll also be contributing valuable information that could improve care for many women in the future. As with any medical study, there are potential risks, though these are typically minimal for follow-up appointments and could involve discomfort during procedures like colposcopy or HPV testing. You are free to withdraw from the study at any time for any reason, without it affecting your medical care.

Locations (1)

Centre de recherche du CHUM
Verified postcode
Montreal, Canada

Common questions

What is 'precancerous cells'?

These are changes in the cells of your cervix that are not cancer yet, but could turn into cancer if not treated. They are also called 'high-grade cervical intra-epithelial neoplasia'.

What is HPV?

HPV stands for Human Papillomavirus, a common virus that can cause these precancerous cell changes in the cervix.

What is a colposcopy?

It's a procedure where a doctor uses a special magnifying tool to look closely at your cervix for any abnormal areas.

Why is this study important?

It's comparing two ways to check for problems after treatment for precancerous cells to find out which method is better at catching any issues early, which could improve future care for women.

Will I get treatment if problems are found?

Yes, if the study finds any problems, you will be offered further treatment straight away.