Clinical trial NCT05420233: The CROCO Study: CROhn's Disease COhort Study
Official title: The CROCO Study: CROhn's Disease COhort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn DII
Lead sponsor: GLSMED Learning Health S.A.
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2022-06-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Lémann Index Y1
timeFrame: 1 year after diagnosis
measure: Lémann Index Y3
timeFrame: 3 years after diagnosis
measure: Lémann Index Y5
timeFrame: 5 years after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital CHU of Liège
city: Stróvolos
country: Cyprus
facility: American Gastroenterology Center
city: Praha
country: Czechia
facility: IBD Clinical and Research Clinic, ISCARE
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Slagelse
country: Denmark
facility: Slagelse Hospital
city: Amiens
country: France
facility: CHU Amiens-Picardie Hôpital Sud
city: Clermont-Ferrand
country: France
facility: CHU Estaing Clermont - Ferrand
city: Lille
country: France
facility: Claude Huriez Hospital, Lille University
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: San Raffaele
country: Italy
facility: Ospedale San Raffaele
city: Imsida
country: Malta
facility: Mater dei hospital
city: Almada
country: Portugal
facility: Hospital Garcia da Orta
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Timişoara
country: Romania
facility: Algomed Policlinic
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro - Área Sanitária de Vigo
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: St Mark's Hospital
Study officials:
affiliation: Luz Saude
name: Joana T Torres, Phd
role: PRINCIPAL_INVESTIGATOR
References: