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

July 27, 2026 updated by: GLSMED Learning Health S.A.
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

Active, not recruiting

Conditions

Intervention / Treatment

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 (Actual)

533

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Liège
      • Liège, Liège, Belgium
        • University Hospital CHU of Liège
  • Cyprus
      • Stróvolos, Cyprus
        • American Gastroenterology Center
  • Czechia
      • Prague, Czechia
        • IBD Clinical and Research Clinic, ISCARE
  • Denmark
      • Hvidovre, Denmark
        • Hvidovre Hospital
      • Slagelse, Denmark
        • Slagelse Hospital
  • France
      • Amiens, France
        • CHU Amiens-Picardie Hôpital Sud
      • Clermont-Ferrand, France
        • CHU Estaing Clermont - Ferrand
      • Lille, France
        • Claude Huriez Hospital, Lille University
  • Italy
      • Padova, Italy
        • Azienda Ospedaliera di Padova
  • Malta
      • Msida, Malta
        • Mater dei hospital
  • Portugal
    • Almada
      • Almada, Almada, Portugal
        • Hospital Garcia da Orta
    • Lisbon District
      • Lisbon, Lisbon District, Portugal
        • Instituto Portugues de Oncologia de Lisboa
    • Loures
      • Loures, Loures, Portugal
        • Hospital Beatriz Angelo
  • Romania
      • Timișoara, Romania
        • Algomed Policlinic
  • Spain
      • Barcelona, Spain
        • Hospital Clinic Barcelona
      • Galdakao, Spain
        • Hospital Galdakao-Usansolo
      • Vigo, Spain
        • Hospital Alvaro Cunqueiro - Área Sanitária de Vigo
  • United Kingdom
      • Hull, United Kingdom
        • Hull University Teaching Hospitals NHS Trust
      • London, United Kingdom
        • St Mark's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 year after diagnosis

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
Time Frame: 3 years after diagnosis

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
Time Frame: 5 years after diagnosis

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

This is where you will find people and organizations involved with this study.

Sponsor

GLSMED Learning Health S.A.

Collaborators

AbbVie

Investigators

  • Principal Investigator: Joana T Torres, Phd, Luz Saude

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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