The CROCO Study: CROhn's Disease COhort Study

Last updated: December 6, 2024
Sponsor: GLSMED Learning Health S.A.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

MRE

Clinical Study ID

NCT05420233
The CROCO Study
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA

To be eligible all of the following criteria must be met:

  • Diagnosis of CD (according to ECCO guidelines) established within the past 12months;

  • Patients able to understand the information provided to them and to give writteninformed consent for the study;

  • Male or female, age > 18 years.

Exclusion

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 reasonthat makes resonance not feasible throughout the study (eg claustrophobia).

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: MRE
Phase:
Study Start date:
August 01, 2021
Estimated Completion Date:
July 31, 2030

Study 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.

Connect with a study center

  • University Hospital CHU of Liège

    Liège,
    Belgium

    Active - Recruiting

  • American Gastroenterology Center

    Stróvolos,
    Cyprus

    Active - Recruiting

  • IBD Clinical and Research Clinic, ISCARE

    Praha,
    Czechia

    Active - Recruiting

  • Hvidovre Hospital

    Hvidovre,
    Denmark

    Active - Recruiting

  • Slagelse Hospital

    Slagelse,
    Denmark

    Active - Recruiting

  • CHU Amiens-Picardie Hôpital Sud

    Amiens,
    France

    Active - Recruiting

  • CHU Estaing Clermont - Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Claude Huriez Hospital, Lille University

    Lille,
    France

    Active - Recruiting

  • Azienda Ospedaliera di Padova

    Padova,
    Italy

    Site Not Available

  • Ospedale San Raffaele

    San Raffaele,
    Italy

    Site Not Available

  • Mater dei hospital

    Imsida,
    Malta

    Active - Recruiting

  • Hospital Garcia da Orta

    Almada,
    Portugal

    Active - Recruiting

  • Instituto Portugues de Oncologia de Lisboa

    Lisboa,
    Portugal

    Active - Recruiting

  • Hospital Beatriz Angelo

    Loures,
    Portugal

    Active - Recruiting

  • Algomed Policlinic

    Timişoara,
    Romania

    Active - Recruiting

  • Hospital Clinic Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Galdakao-Usansolo

    Galdakao,
    Spain

    Active - Recruiting

  • Hospital Alvaro Cunqueiro - Área Sanitária de Vigo

    Vigo,
    Spain

    Active - Recruiting

  • Hull University Teaching Hospitals NHS Trust

    Hull,
    United Kingdom

    Active - Recruiting

  • St Mark's Hospital

    London,
    United Kingdom

    Active - Recruiting

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