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The CROCO Study: CROhn's Disease COhort Study

NCT ID: NCT05420233

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2030-07-31

Brief Summary

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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

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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

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Crohn Disease

Keywords

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Crohn DII

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

MRE

Intervention Type DIAGNOSTIC_TEST

Magnetic Resonance Enterography at year 1 (in some patients)

Interventions

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MRE

Magnetic Resonance Enterography at year 1 (in some patients)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Magnetic Resonance Enterography

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

GLSMED Learning Health S.A.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joana T Torres, Phd

Role: PRINCIPAL_INVESTIGATOR

Luz Saude

Locations

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University Hospital CHU of Liège

Liège, Liège, Belgium

Site Status RECRUITING

American Gastroenterology Center

Stróvolos, , Cyprus

Site Status RECRUITING

IBD Clinical and Research Clinic, ISCARE

Prague, , Czechia

Site Status RECRUITING

Hvidovre Hospital

Hvidovre, , Denmark

Site Status RECRUITING

Slagelse Hospital

Slagelse, , Denmark

Site Status RECRUITING

CHU Amiens-Picardie Hôpital Sud

Amiens, , France

Site Status RECRUITING

CHU Estaing Clermont - Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Claude Huriez Hospital, Lille University

Lille, , France

Site Status RECRUITING

Azienda Ospedaliera di Padova

Padua, , Italy

Site Status NOT_YET_RECRUITING

Ospedale San Raffaele

San Raffaele, , Italy

Site Status WITHDRAWN

Mater dei hospital

Msida, , Malta

Site Status RECRUITING

Hospital Garcia da Orta

Almada, Almada, Portugal

Site Status RECRUITING

Instituto Portugues de Oncologia de Lisboa

Lisbon, Lisbon District, Portugal

Site Status RECRUITING

Hospital Beatriz Angelo

Loures, Loures, Portugal

Site Status RECRUITING

Algomed Policlinic

Timișoara, , Romania

Site Status RECRUITING

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Galdakao-Usansolo

Galdakao, , Spain

Site Status RECRUITING

Hospital Alvaro Cunqueiro - Área Sanitária de Vigo

Vigo, , Spain

Site Status RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, , United Kingdom

Site Status RECRUITING

St Mark's Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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Belgium Cyprus Czechia Denmark France Italy Malta Portugal Romania Spain United Kingdom

Central Contacts

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Raquel C Ribeiro, Dr

Role: CONTACT

Phone: 00351917483203

Email: [email protected]

Rita C Eça, Dr

Role: CONTACT

Email: [email protected]

Facility Contacts

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Sophie Vieujean

Role: primary

Ioannis Kaimakliotis

Role: primary

Dana Duricova

Role: primary

Johan Burisch

Role: primary

Natalia Pedersen

Role: primary

Mathurin Fumery

Role: primary

Anthony Buisson

Role: primary

Maria Nachury

Role: primary

Brigida Barberio

Role: primary

Pierre Elul

Role: primary

Irina Mocanu

Role: primary

Daniel Conceição

Role: primary

Joana Torres, PhD

Role: primary

Adrian Goldis

Role: primary

Ingrid Ordas

Role: primary

Iago Lago

Role: primary

Vicent Hernandez

Role: primary

Shaji Sebastian

Role: primary

Naila Arebi

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40895198 (View on PubMed)

Other Identifiers

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The CROCO Study

Identifier Type: -

Identifier Source: org_study_id