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RecruitingNAINTERVENTIONAL

The CROCO Study: CROhn's Disease COhort Study

The CROCO Study is helping us learn more about Crohn's disease over five years. We're following people who have recently been diagnosed and are receiving the most up-to-date treatments. By regularly checking their disease, we aim to understand how it progresses and how different treatments affect it in the long run. We also want to find early signs that could tell us how severe the disease might become. This will help doctors make better treatment plans and improve the lives of people with Crohn's disease. We'll be using special scans to see changes in the gut and collecting information about their health along the way.

At a glance

Status
Recruiting
Phase
NA
Sponsor
GLSMED Learning Health S.A.
Enrolment target
600
Start
01 Aug 2021
Estimated completion
01 Jul 2030

What is this study about?

The CROCO Study is all about understanding Crohn's disease better. Crohn's disease is a long-term condition that causes inflammation in the digestive system. Because it's different for everyone, doctors and researchers want to learn more about how it changes over time, especially with the newest treatments available today.

This study will follow 600 people who have recently been diagnosed with Crohn's disease over five years. By carefully observing their health, treatments, and how their disease progresses, the study hopes to find out what factors lead to clearer and more accurate predictions about how the disease will affect someone in the future. This kind of information is really important because it helps doctors choose the best treatments and manage the disease more effectively, aiming to improve the quality of life for people with Crohn's.

To do this, the study will collect lots of information, including regular check-ups, blood tests, and special scans called MREs (Magnetic Resonance Enterography) to look at the gut. All this information will help researchers understand how treatments work in the long term, track how the disease changes in the body, and ultimately develop better ways to help people living with Crohn's disease.

Key takeaways

  • The study aims to understand how Crohn's disease progresses over 5 years.
  • It follows people newly diagnosed with Crohn's on current treatments.
  • Participation involves regular visits, blood tests, and MRI scans.
  • The goal is to improve future treatments and predict disease severity.
  • You continue standard Crohn's care while participating.

Who may be eligible?

To join the CROCO Study, you must be an adult aged 18 or over and have been diagnosed with Crohn's disease within the last 12 months. It's important that you understand what the study involves and are happy to give your written consent to take part.

There are some reasons why you might not be able to join. For example, if you are pregnant, have a serious medical condition that means you're unlikely to live for at least two more years, or if you cannot have the regular scans because of another health problem (like kidney issues) or strong claustrophobia. Also, if there's any doubt about your Crohn's diagnosis, you wouldn't be able to participate. Most importantly, you need to be willing to take part and follow the study's requirements.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with Crohn's disease within the last 12 months?
  3. Are you able to understand the study and agree to take part?
  4. Are you able to have MRI scans safely (e.g., no severe claustrophobia)?
  5. Are you not pregnant?
Answer every question to see your result.

What does participation involve?

If you join the CROCO Study, you will be followed for five years after your Crohn's diagnosis. This means you'll have regular visits where doctors will check your health, collect blood and other samples, and ask you to fill out questionnaires about how the disease affects your daily life. After the first year, you'll have visits every six months.

Crucially, you will have special scans called MREs (Magnetic Resonance Enterography) at 1, 3, and 5 years after your diagnosis. Depending on where your disease is located, you might also have other tests like colonoscopies, endoscopies, or pelvic MRI scans. You will continue to receive the standard treatments that your doctor recommends for your Crohn's disease throughout the study. Any surgeries you have during this time will also be recorded.

Potential risks and benefits

Taking part in this study could help doctors learn more about Crohn's disease, which might lead to better treatments for everyone in the future. While there are no direct benefits to you as an individual, you'll be closely monitored by your healthcare team. The main risks involve the extra appointments and scans, and some people find MRI scans uncomfortable or feel claustrophobic. You are completely free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (20)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Hospital CHU of Liège
    Verified postcode
    Liège, Belgium· Recruiting
  • American Gastroenterology Center
    Verified postcode
    Stróvolos, Cyprus· Recruiting
  • IBD Clinical and Research Clinic, ISCARE
    Verified postcode
    Prague, Czechia· Recruiting
  • Hvidovre Hospital
    Verified postcode
    Hvidovre, Denmark· Recruiting
  • Slagelse Hospital
    Verified postcode
    Slagelse, Denmark· Recruiting
  • CHU Amiens-Picardie Hôpital Sud
    Verified postcode
    Amiens, France· Recruiting
  • CHU Estaing Clermont - Ferrand
    Verified postcode
    Clermont-Ferrand, France· Recruiting
  • Claude Huriez Hospital, Lille University
    Verified postcode
    Lille, France· Recruiting
  • Azienda Ospedaliera di Padova
    Verified postcode
    Padova, Italy· Not yet recruiting
  • Ospedale San Raffaele
    Verified postcode
    San Raffaele, Italy· Withdrawn
  • Mater dei hospital
    Verified postcode
    Msida, Malta· Recruiting
  • Hospital Garcia da Orta
    Verified postcode
    Almada, Portugal· Recruiting

Common questions

What is the main goal of the CROCO Study?

The main goal is to better understand how Crohn's disease changes over time and how different treatments affect it in the long run.

How long will I be involved in the study?

You'll be followed for five years after your Crohn's disease diagnosis.

Will I still receive my regular Crohn's medication?

Yes, you will continue to receive the standard care and treatments your doctor recommends for your Crohn's disease.

What kind of tests will I have?

You'll have regular check-ups, blood tests, and special MRE scans at 1, 3, and 5 years. Other scans might be needed depending on your disease.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your usual medical care.

How to find out more

Raquel C Ribeiro, Dr

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

Interested in taking part?

Register your interest

Share your details and the research team for "The CROCO Study: CROhn's Disease COhort Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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