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

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ClinicalTrials.gov Identifier: NCT05420233
Recruitment Status : Recruiting
First Posted : June 15, 2022
Last Update Posted : June 15, 2022
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
GLSMED Learning Health S.A.

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Diagnostic Test: MRE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The CROCO Study: CROhn's Disease COhort Study
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 2028
Estimated Study Completion Date : August 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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 Name: Magnetic Resonance Enterography




Primary Outcome Measures :
  1. 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.


  2. 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. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05420233


Contacts
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Contact: Raquel C Ribeiro, Dr 00351917483203 croco.study@gmail.com
Contact: Rita C Eça, Dr rheca@hospitaldaluz.pt

Locations
Show Show 20 study locations
Sponsors and Collaborators
GLSMED Learning Health S.A.
AbbVie
Investigators
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Principal Investigator: Joana T Torres, Phd Luz Saude
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Responsible Party: GLSMED Learning Health S.A.
ClinicalTrials.gov Identifier: NCT05420233    
Other Study ID Numbers: The CROCO Study
First Posted: June 15, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GLSMED Learning Health S.A.:
Crohn DII
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases