The CROCO Study: CROhn's Disease COhort Study

Crohn Disease Clinical Trial

— CROCO  

Official title:

The CROCO Study: CROhn's Disease COhort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420233
• Other study ID #: The CROCO Study
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 2028

Study information

• Verified date: September 2023
• Source: GLSMED Learning Health S.A.
• Contact: Raquel C Ribeiro, Dr
• Phone: 00351917483203
• Email: croco.study[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Diagnostic Test:
• MRE
Magnetic Resonance Enterography at year 1 (in some patients)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
GLSMED Learning Health S.A.	AbbVie

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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