The CROCO Study: CROhn's Disease COhort Study

NCT05420233 | Recruiting

• 1 other identifier: The CROCO Study
• Study Type: interventional
• Target: 600
• Locations: 11 countries
• Sites: 20

Brief 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.

Conditions

Crohn Disease

Keywords

Crohn DII

Outcome Measures

Primary Outcomes (3)

• Lémann Index Y1

  The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD). Descriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage. Time to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements. Lémann Index is a continuous variable.

  1 year after diagnosis

• Lémann Index Y3

  The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD). Descriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage. Time to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements. Lémann Index is a continuous variable.

  3 years after diagnosis

• Lémann Index Y5

  The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD). Descriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage. Time to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements. Lémann Index is a continuous variable.

  5 years after diagnosis

Study Arms (1)

Patients diagnosed with Crohn´s disease within the past 12 months

OTHER

All patients will undergo MRE in year 1, and this test may not be recommended in all patients. Year 1 MRE is the only procedure that may be performed outside of clinical practice.

Diagnostic Test: MRE

Interventions

MRE DIAGNOSTIC_TEST

Magnetic Resonance Enterography at year 1 (in some patients)

Also known as: Magnetic Resonance Enterography

Patients diagnosed with Crohn´s disease within the past 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GLSMED Learning Health S.A.: lead
• AbbVie: collaborator

Study Sites (20)

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

Padua, 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

Related Publications (1)

• Reves J, Buisson A, Burisch J, Arebi N, Ungaro R, Vieujean S, Cravo M, Ellul P, Duricova D, Sebastian S, Rodriguez-Lago I, Ordas I, Kaimakliotis I, Hernandez V, Mocanu I, Nachury M, Goldis A, Fumery M, Conceicao D, Pedersen NK, Guedes AF, Ribeiro R, Bigot N, Mary JY, Lambert J, Colombel JF, Torres J; CROCO Study Group. The CROCO (CROhn's Disease COhort Study) - study design and protocol. Therap Adv Gastroenterol. 2025 Aug 29;18:17562848251362594. doi: 10.1177/17562848251362594. eCollection 2025.

  PMID: 40895198 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Joana T Torres, Phd

  Luz Saude

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel C Ribeiro, Dr

CONTACT

00351917483203; croco.study@gmail.com

Rita C Eça, Dr

CONTACT

rheca@hospitaldaluz.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 15, 2022
• Study Start: August 1, 2021
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: December 11, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); PT (3); FR (3); RO (1); GB (2); BE (1); CY (1); CZ (1); MA (1); IT (2); ES (3)