Cohort study on Crohn's Disease progression and treatment
The CROCO Study: CROhn's Disease COhort Study
This study is trying to see how Crohn's Disease changes over time in newly diagnosed patients and how different treatments can help manage it better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GLSMED Learning Health S.A. Academic / other |
| Locations | 20 sites (Liège, Liège and 19 other locations) |
| Trial ID | NCT05420233 on ClinicalTrials.gov |
What this trial studies
The CROCO Study aims to create a prospective cohort of patients diagnosed with Crohn's Disease (CD) within the last year, who will be closely monitored over a five-year period. This multicenter study will include 600 patients and utilize a treat-to-target strategy with the latest therapies, assessing disease progression through the Lémann Index and various imaging techniques. Patients will undergo regular evaluations, including clinical and laboratory assessments, to understand the long-term evolution of CD and the impact of different treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been diagnosed with Crohn's Disease within the past 12 months.
Not a fit: Patients with severe underlying medical conditions, uncertain CD diagnosis, or those unable to undergo necessary imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies and better outcomes for patients with Crohn's Disease.
How similar studies have performed: Other studies focusing on the long-term management and progression of Crohn's Disease have shown promising results, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA To be eligible all of the following criteria must be met: * Diagnosis of CD (according to ECCO guidelines) established within the past 12 months; * Patients able to understand the information provided to them and to give written informed consent for the study; * Male or female, age \> 18 years. EXCLUSION CRITERIA: * Patients unwilling or unable to provide informed, written consent; * Severe underlying medical disorder with an anticipated life expectancy \< 2 years; * Refusal or medical conditions (e.g. Glomerular filtration rate \< 30 mL/min) preventing cross-sectional imaging during follow-up; * Uncertain CD diagnosis; * Pregnancy (if it is impossible to implement the MRE at one year) or any other reason that makes resonance not feasible throughout the study (eg claustrophobia).
Where this trial is running
Liège, Liège and 19 other locations
- University Hospital CHU of Liège — Liège, Liège, Belgium (Recruiting)
- American Gastroenterology Center — Stróvolos, Cyprus (Recruiting)
- IBD Clinical and Research Clinic, ISCARE — Prague, Czechia (Recruiting)
- Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
- Slagelse Hospital — Slagelse, Denmark (Recruiting)
- CHU Amiens-Picardie Hôpital Sud — Amiens, France (Recruiting)
- CHU Estaing Clermont - Ferrand — Clermont-Ferrand, France (Recruiting)
- Claude Huriez Hospital, Lille University — Lille, France (Recruiting)
- Azienda Ospedaliera di Padova — Padova, Italy (Not_yet_recruiting)
- Ospedale San Raffaele — San Raffaele, Italy (Withdrawn)
- Mater dei hospital — Msida, Malta (Recruiting)
- Hospital Garcia da Orta — Almada, Almada, Portugal (Recruiting)
- Instituto Portugues de Oncologia de Lisboa — Lisbon, Lisbon District, Portugal (Recruiting)
- Hospital Beatriz Angelo — Loures, Loures, Portugal (Recruiting)
- Algomed Policlinic — Timișoara, Romania (Recruiting)
- Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
- Hospital Galdakao-Usansolo — Galdakao, Spain (Recruiting)
- Hospital Alvaro Cunqueiro - Área Sanitária de Vigo — Vigo, Spain (Recruiting)
- Hull University Teaching Hospitals NHS Trust — Hull, United Kingdom (Recruiting)
- St Mark's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Joana T Torres, Phd — Luz Saude
- Study coordinator: Raquel C Ribeiro, Dr
- Email: croco.study@gmail.com
- Phone: 00351917483203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.