RecruitingOBSERVATIONAL

PIBD-SETQuality: the Inception Cohort and Safety Registry

This study, called PIBD-SETQuality, is not testing new treatments but observing how current ones work for children and teenagers with Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. Researchers want to see how effective these treatments are and if they have any side effects during everyday care. They are also curious if a young person's individual background affects how well treatments work. Additionally, the study aims to track rare but serious problems related to IBD or its treatments across a wider group of young patients. The goal is to learn more about IBD in young people and improve their care without asking anyone to try new or experimental medicines.

At a glance

Status

Recruiting

Sponsor

PIBD-Net

Enrolment target

1,500

Start

03 Jan 2017

Estimated completion

31 Dec 2027

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

What is this study about?

This study is called PIBD-SETQuality, and it's looking into Inflammatory Bowel Diseases (IBD) in children and teenagers. IBD includes conditions like Crohn's disease and ulcerative colitis. Instead of testing new medicines, it's an 'observational study,' which means doctors are simply watching and learning from the treatments that young patients are already receiving as part of their regular care. They want to understand how effective these treatments are and if they cause any side effects.

One main part of the study focuses on young people who have recently been diagnosed with IBD. For these individuals, researchers will collect information about their treatment choices and how they respond over time. They are also interested in whether a child's unique health profile or background might influence how well a particular treatment works for them. By gathering this real-world information, the study hopes to find patterns that could help doctors make better treatment decisions in the future.

Another important part of this study is a 'safety registry.' This registry collects information about rare but serious problems that might happen to young people with IBD, either related to their condition itself or their treatments. By tracking these complications, the study aims to get a better idea of how often they occur and what factors might contribute to them. All this information helps the medical community understand IBD in young people more deeply, which can lead to improvements in diagnosis and care.

Key takeaways

This study helps doctors learn more about treatments for IBD in young people.
It's an 'observational study,' meaning researchers watch current treatments, not test new ones.
No new medicines, tests, or procedures are involved for participants.
Information from newly diagnosed patients and those with complications is collected.
Participation could improve future care for young people with IBD.
You can withdraw from the study at any time without affecting your medical treatment.

Who may be eligible?

This study is looking for two main groups of young people with Inflammatory Bowel Disease (IBD). The first group is for children and teenagers, up to 18 years old, who have recently been diagnosed with IBD. To join this part of the study, their IBD diagnosis must be confirmed by doctors using standard tests, and this confirmation needs to have happened within the last two months. Also, if they are able to understand, both the young person and their parents will need to agree to take part. Importantly, if biological samples (like blood) are being collected, the child should not have started IBD treatment yet at the time of inclusion.

The second group is a 'safety registry,' which can include any child or teenager up to 19 years old with IBD who experiences certain serious complications related to their condition. This part of the study aims to collect information on these less common but important health issues.

Generally, you wouldn't be able to join the first group (for newly diagnosed patients) if you or your parents can't understand the study information, or if you are already on IBD-like treatments for other health conditions that might interfere with how your IBD is understood in the study.

Quick self-check

Are you or your child under 18 years old and newly diagnosed with Inflammatory Bowel Disease (IBD)?
Has the IBD diagnosis been confirmed by a doctor within the last two months?
Are you and your child (if they can understand) able to read and understand the study information, or do you have help to do so?
Are you willing for your child's routine medical information to be shared for research purposes? (For newly diagnosed patients, if samples are collected, have they not started IBD treatment yet?)
If your child has IBD and has experienced a specific serious complication, are they under 19 years old?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the main part of this study as a newly diagnosed patient, your involvement will mostly be about allowing the research team to collect information from your existing medical records. This includes details from your doctor's visits, test results (like blood tests, endoscopies, X-rays), and information about the treatments you are already receiving for your Inflammatory Bowel Disease (IBD). You won't be asked to change any of your current medications or undergo any extra medical procedures specifically for this study. The study aims to learn from what's already happening in your regular care. There will be no extra visits to the hospital or clinic solely for this research. The information collected will be ongoing as long as you are receiving care for your IBD, helping researchers understand the long-term journey of young people with IBD. For the safety registry, doctors will report information about specific complications if they happen.

Potential risks and benefits

Because this study only collects information from your routine medical care and doesn't involve any new treatments or procedures, there are no direct physical risks to participating. The main potential benefit is that the information gathered from your journey, combined with that from many other young people, will help doctors better understand Inflammatory Bowel Disease and improve care for future patients. This study will not directly change your medical treatment. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (2)

Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands· Recruiting
Royal Hospital London
London, United Kingdom· Recruiting

Common questions

Will I have to take new medicine or get extra tests for this study?

No, this study only collects information from your regular doctor's visits and treatments. You will not receive any new medicines or extra tests just for the study.

What is the difference between an 'inception cohort' and a 'safety registry'?

An 'inception cohort' tracks newly diagnosed patients over time. A 'safety registry' collects information about rare but serious medical problems happening to patients already being treated.

Who will see my personal information if I join?

All your personal information will be kept strictly private. The researchers will use coded information and follow strict rules to protect your identity.

Will joining this study change my regular treatment?

No, your medical team will continue to make all treatment decisions based on what's best for your health, just as they normally would. The study won't interfere with your care.

Can I leave the study if I change my mind?

Yes, you or your parents can decide to stop participating at any time, for any reason. It won't affect the care you receive from your doctors.

How to find out more

Frank Ruemmele, MD, PhD

frank.ruemmele@nck.aphp.fr Official trial record

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