Crohn DiseaseCROCONCT05420233
The CROCO Study: CROhn's Disease COhort Study
A study testing MRE in people with Crohn Disease, run by GLSMED Learning Health S.A. at 19 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- MRE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 19 sitesin 11 countries
- Study dates
- 1 Aug 2021to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
19 sites in 11 countries.
19 sites in 11 countries
France3 sites
CHU Amiens-Picardie Hôpital Sud
Amiens
CHU Estaing Clermont - Ferrand
Clermont-Ferrand
Claude Huriez Hospital, Lille University
Lille
Portugal3 sites
Hospital Garcia da Orta
Almada, Almada
Instituto Portugues de Oncologia de Lisboa
Lisbon, Lisbon District
Hospital Beatriz Angelo
Loures, Loures
Spain3 sites
Hospital Clinic Barcelona
Barcelona
Hospital Galdakao-Usansolo
Galdakao
Hospital Alvaro Cunqueiro - Área Sanitária de Vigo
Vigo
United Kingdom2 sites
Hull University Teaching Hospitals NHS Trust
Hull
St Mark's Hospital
London
About this study
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- MRE
- Keywords
- Crohn DII
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MREDiagnostic test
Also called Magnetic Resonance Enterography
Magnetic Resonance Enterography at year 1 (in some patients)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: MRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Aug 2021
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- GLSMED Learning Health S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Joana T Torres, Phd, Principal investigator, Luz Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420233
- Sponsor's protocol ID
- The CROCO Study
- Acronym
- CROCO
- Status last verified
- Jul 2026
- First submitted
- 25 May 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. Ther Adv Gastroenterol. 2025 Aug 29;18:17562848251362594. doi: 10.1177/17562848251362594. eCollection 2025.
PubMed 40895198
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CROCO Study: CROhn's Disease COhort Study
- ClinicalTrials.gov ID
- NCT05420233
- Acronym / sponsor ID
- CROCO / The CROCO Study
- Conditions
- Crohn Disease
- Keywords
- Crohn DII
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 533 participants (actual)
- Lead sponsor
- GLSMED Learning Health S.A.University, hospital or other
- Collaborators
- AbbVie
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with Crohn´s disease within the past 12 months | Other | Diagnostic Test: MREAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MREAlso: Magnetic Resonance EnterographyMagnetic Resonance Enterography at year 1 (in some patients) | Diagnostic test | Patients diagnosed with Crohn´s disease within the past 12 months |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Derived from this study: PubMed 40895198Reves 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. Ther Adv Gastroenterol. 2025 Aug 29;18:17562848251362594. doi: 10.1177/17562848251362594. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joana T Torres, Phd principal investigator
Luz Saude
19 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRE in people with Crohn Disease, run by GLSMED Learning Health S.A. at 19 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Portugal, Spain, Denmark, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lémann Index Y1 (time frame: 1 year after diagnosis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.