Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
ACTIVE NOT RECRUITINGNA

The CROCO Study: CROhn's Disease COhort Study

Sponsor: GLSMED Learning Health S.A.

NCT ID: NCT05420233

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MRE (diagnostic test)
How long the study runs
Study runs about 107 months (dates as stated)
About the drug or intervention
MRE — diagnostic test: Magnetic Resonance Enterography at year 1 (in some patients)
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
533
Started
2021-08-01
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for crohn disease
  • • NA - 533 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with crohn disease

Where?

  • • Hull - Hull University Teaching Hospitals NHS Trust
  • • London - St Mark's Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Crohn Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Who cannot take part

  • ✗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...
  • ✗Uncertain CD diagnosis;
  • ✗Pregnancy (if it is impossible to implement the MRE at one year) or any other reason that makes resonance not...
See the full 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).

Where Is This Study? (2 UK sites)

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

St Mark's Hospital

London, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-07