RecruitingNot ApplicableNCT05420233

The CROCO Study: CROhn's Disease COhort Study


Sponsor

GLSMED Learning Health S.A.

Enrollment

600 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators propose to create a prospective Crohn Disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of Crohn Disease by measuring the Lémann Index over time. The goal of the CROCO Study - "Crohn's Disease Cohort Study" is to promote a greater understanding of the long-term evolution of Crohn Disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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).

Interventions

DIAGNOSTIC_TESTMRE

Magnetic Resonance Enterography at year 1 (in some patients)


Locations(20)

University Hospital CHU of Liège

Liège, Liège, Belgium

American Gastroenterology Center

Stróvolos, Cyprus

IBD Clinical and Research Clinic, ISCARE

Prague, Czechia

Hvidovre Hospital

Hvidovre, Denmark

Slagelse Hospital

Slagelse, Denmark

CHU Amiens-Picardie Hôpital Sud

Amiens, France

CHU Estaing Clermont - Ferrand

Clermont-Ferrand, France

Claude Huriez Hospital, Lille University

Lille, France

Azienda Ospedaliera di Padova

Padua, Italy

Ospedale San Raffaele

San Raffaele, Italy

Mater dei hospital

Msida, Malta

Hospital Garcia da Orta

Almada, Almada, Portugal

Instituto Portugues de Oncologia de Lisboa

Lisbon, Lisbon District, Portugal

Hospital Beatriz Angelo

Loures, Loures, Portugal

Algomed Policlinic

Timișoara, Romania

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Galdakao-Usansolo

Galdakao, Spain

Hospital Alvaro Cunqueiro - Área Sanitária de Vigo

Vigo, Spain

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

St Mark's Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05420233


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