TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)

ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives

About this trial

Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).

Primary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age

Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.

Indication for MRE based on routine clinical practice validated by the treating physician

Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…).

Disqualifiers

Pregnancy during the study

People unable to give consent (because of their physical or mental state)

Absence of written consent

Ulcerative colitis or unclassified IBD

Trial population

Patients diagnosed with CD for more than 6 months with histological confirmation available in his medical record, with an indication for MRE based on routine clinical practice validated by the treating physician

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic Resonance Enterography (MRE)

    Procedure/Surgery

    MRE performed as part of the standard of care follow up of the patient, the exam will be recorded for the study and analysed by central readers.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD

An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.

Time frame
Day 1

Secondary outcomes

1

Intra- and inter-observer variability of lesions observed per segment during MRE in CD

Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.

Time frame
Day 1
2

Intra- and inter-observer variability of depth and grade of global transmural healing in CD

Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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