The CROCO Study: CROhn's Disease COhort Study (CROCO)

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Diagnostic test: MRE

Detailed Description

Therefore, the investigators designed a prospective, multicentre, study of the clinical course, anatomical progression and treatment of newly diagnosed CD and plan to include 600 patients over a 2-year period. Patients will be followed over 5 years after diagnosis (the date of diagnosis will be the date of the index histopathology describing CD; in special situations where pathology is not available the date of diagnosis will be the date that CD was declared by the physician). A morphological evaluation (LI), using abdominal magnetic resonance, will be performed at 1, 3 and 5 years after diagnosis. Ileocolonoscopy, upper endoscopy and/or pelvic MRI will be included according to disease location. Patients will be treated with standard of care therapy and will be followed for 5 years after diagnosis, with semestrial visits after the Year 1 (LI 1). At each visit, clinical and laboratory markers will be collected. Perianal and abdominal surgeries during follow-up will be registered. The disability index questionnaire will also be recorded every year.

A preliminary requisite is therefore to implement and standardize examination reports and damage definitions used to calculate the LI. To this end, training session, supervised by members of the steering committee, will be held for participating gastroenterologist and radiologists. Based on commented ileocolonoscopy, upper endoscopy abdominal MRI and pelvic MRI, these sessions will highlight how lesions should be characterized and graded accordingly to implement the Lémann Index.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raquel C Ribeiro, Dr; Phone Number: 00351917483203; Email: croco.study@gmail.com
• Study Contact Backup: Name: Rita C Eça, Dr; Email: rheca@hospitaldaluz.pt

Study Locations

• Belgium
  • Liège, Belgium
    • Recruiting
    • University Hospital CHU of Liège
    • Contact: Sophie Vieujean
• Cyprus
  • Stróvolos, Cyprus
    • Recruiting
    • American Gastroenterology Center
    • Contact: Ioannis Kaimakliotis
• Czechia
  • Praha, Czechia
    • Recruiting
    • IBD Clinical and Research Clinic, ISCARE
    • Contact: Dana Duricova
• Denmark
  • Hvidovre, Denmark
    • Recruiting
    • Hvidovre Hospital
    • Contact: Johan Burisch
  • Slagelse, Denmark
    • Recruiting
    • Slagelse Hospital
    • Contact: Natalia Pedersen
• France
  • Amiens, France
    • Recruiting
    • CHU Amiens-Picardie Hôpital Sud
    • Contact: Mathurin Fumery
  • Clermont-Ferrand, France
    • Recruiting
    • CHU Estaing Clermont - Ferrand
    • Contact: Anthony BUISSON
  • Lille, France
    • Recruiting
    • Claude Huriez Hospital, Lille University
    • Contact: Maria Nachury
• Italy
  • Padova, Italy
    • Not yet recruiting
    • Azienda Ospedaliera di Padova
    • Contact: Brigida Barberio
  • San Raffaele, Italy
    • Withdrawn
    • Ospedale San Raffaele
• Malta
  • Imsida, Malta
    • Recruiting
    • Mater Dei Hospital
    • Contact: Pierre Elul
• Portugal
  • Almada, Portugal
    • Recruiting
    • Hospital Garcia da Orta
    • Contact: Irina Mocanu
  • Lisboa, Portugal
    • Recruiting
    • Instituto Português de Oncologia de Lisboa
    • Contact: Daniel Conceição
  • Loures, Portugal
    • Recruiting
    • Hospital Beatriz Ângelo
    • Contact: Joana Torres, PhD
• Romania
  • Timişoara, Romania
    • Recruiting
    • Algomed Policlinic
    • Contact: Adrian Goldis
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic Barcelona
    • Contact: Ingrid Ordas
  • Galdakao, Spain
    • Recruiting
    • Hospital Galdakao-Usansolo
    • Contact: Iago Lago
  • Vigo, Spain
    • Recruiting
    • Hospital Alvaro Cunqueiro - Área Sanitária de Vigo
    • Contact: Vicent Hernandez
• United Kingdom
  • Hull, United Kingdom
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust
    • Contact: Shaji Sebastian
  • London, United Kingdom
    • Recruiting
    • St Mark's Hospital
    • Contact: Naila Arebi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients diagnosed with Crohn´s disease within the past 12 months; 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; Magnetic Resonance Enterography at year 1 (in some patients); Other Names: Magnetic Resonance Enterography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GLSMED Learning Health S.A.
• Collaborators: AbbVie
• Investigators: Principal Investigator: Joana T Torres, Phd, Luz Saude

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 11, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Crohn DII
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: The CROCO Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No