RecruitingOBSERVATIONAL

Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN

This study, called SUIVICIN, is for women aged 18 to 39 with a mild abnormal cell change called CIN2 (Cervical Intraepithelial Neoplasia Grade 2). Instead of having immediate surgery (conization), the study wants to see if regular monitoring and waiting can be a safe alternative. CIN2 often clears up on its own, so researchers are checking if avoiding surgery for at least two years, and possibly four, is a good option. The main goal is to understand how often CIN2 disappears without treatment and if this approach can avoid surgery-related risks, like problems with future pregnancies, for suitable patients.

At a glance

Status

Recruiting

Sponsor

University Hospital, Bordeaux

Enrolment target

200

Start

23 Aug 2019

Estimated completion

01 Sep 2029

HPV Infection Cervical Cancer

What is this study about?

This study is looking at a condition called CIN2, which stands for Cervical Intraepithelial Neoplasia Grade 2. This means there are some abnormal cells on the surface of your cervix – the neck of your womb. It's not cancer, but if left untreated, it could potentially develop into cancer over time. Currently, the standard treatment for CIN2 often involves a minor surgical procedure called conization, which removes the abnormal cells.

However, we know that CIN2 often clears up by itself, especially in younger women. This study wants to find out if it's safe for women aged 18 to 39 with CIN2 to be carefully watched with regular checks instead of having surgery straight away. The researchers will observe these women for at least two years, and possibly up to four years, to see if their CIN2 naturally disappears or improves. The aim is to understand if this 'wait and see' approach can be a good alternative, helping women avoid surgery and its potential side effects, such as a slightly increased risk of premature birth in future pregnancies.

By carefully monitoring instead of immediately treating, this study hopes to provide more options for women with CIN2 who are interested in avoiding surgery. It's building on previous findings that suggest CIN2 can often resolve on its own, and that immediate surgery might not always be necessary, especially for certain groups of women.

Key takeaways

This study explores a 'watch and wait' approach for CIN2 in women aged 18-39.
The goal is to see if CIN2 clears up naturally, avoiding surgery.
If you join, you'll have regular smear tests and colposcopies for 2-4 years.
This approach aims to reduce potential surgery risks, like effects on future pregnancies.
You will be closely monitored, and treatment will be offered if needed.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to women aged between 18 and 39 years old. You would be considered for the study if a recent biopsy has confirmed that you have CIN2 (meaning you have certain abnormal cells on your cervix).

The doctors must be able to get a clear view of the affected area on your cervix during a special examination called a colposcopy. You also need to be a resident of the UK and have access to the National Health Service or a similar social security scheme, and you must agree to take part and have your health information used for the study.

However, you won't be able to join if you are currently pregnant, or if you've had similar cervical surgery (conization) before. Other reasons you couldn't join include having certain types of abnormal cells found in your smear test, if you've had the HPV vaccine, have an active infection, a history of HIV, or certain conditions that weaken your immune system. If you're on long-term steroid treatment or immune-suppressing drugs, or if there's any doubt you'd be able to attend all the necessary follow-up appointments, you would also not be eligible.

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 between 18 and 39?
Has a recent biopsy confirmed you have CIN2?
Are you able to attend regular check-ups for at least two years?
Are you currently pregnant? (If yes, you cannot join)
Have you had cervical surgery (conization) before? (If yes, you cannot join)
Do you have a condition that affects your immune system, or are you on related medication? (If yes, you may not be able to join)

Answer every question to see your result.

What does participation involve?

If you join this study, instead of having immediate surgery for your CIN2, you would be regularly monitored. This involves having check-ups every six months for at least two years, and potentially up to four years. Each check-up would include a cervical smear test, and a colposcopy (where a doctor looks at your cervix with a special microscope). They might also take small tissue samples (biopsies) if needed during these visits. The study doesn't involve new medications, but focuses on careful observation. The total time you'd be involved in the study could be up to four years, depending on how your condition progresses and if the study is extended.

Potential risks and benefits

The main potential benefit of joining this study is the chance to avoid surgery (conization) for your CIN2. This could reduce the risk of potential complications linked to surgery, such as problems in future pregnancies like premature birth, or scarring that can make future check-ups more difficult. The main risk involved is that your CIN2 might not clear up on its own, and in a small number of cases, it could progress. However, you will be very closely monitored, and if there are signs that your CIN2 is not improving or is getting worse, you would be offered treatment. You have the right to withdraw from the study at any time without giving a reason, and this would not affect your future medical care.

Locations (1)

CHU Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is CIN2?

CIN2 means you have moderate abnormal cells on the surface of your cervix. It's not cancer, but it's a condition that doctors monitor closely.

Why would I choose monitoring instead of treatment?

CIN2 often clears up on its own, especially in younger women. Monitoring allows you to see if your body resolves it naturally, potentially avoiding a small surgical procedure and its possible side effects.

Is it safe to wait and watch?

The study aims to confirm the safety of this approach under close medical supervision. You would have regular check-ups, and if your condition changes, treatment would be offered.

What happens if my CIN2 doesn't go away?

If your CIN2 doesn't clear up or if it gets worse during the study, the medical team will discuss and offer you the standard treatments available.

How long will I be in the study?

You would be part of the study for at least two years, and potentially up to four years, with regular check-ups every six months.

How to find out more

Jean-Luc Brun, MD, PhD

jean-luc.brun@chu-bordeaux.fr 335 56 79 59 85 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.