Clinical trial NCT05903066: TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
Official title: TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Keywords: IBD
CD
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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

Detailed description: Number of patients : 210 patients, in 14 sites (only one investigator per site), 15 patients per site, 5 patients per grade of transmural healing based on the appraisal of a local reader pair (a gastroenterologist and a radiologist).

Recruitment period : 2 years

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

Secondary Endpoints :

* To analyze intra- and inter-observer variability of radiological findings.
* To analyze intra- and inter-observer variability of TH definitions in CD.

Eligibility criteria: Inclusion Criteria:

* ≥ 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...).
* The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study.
* A subject can be enrolled into the study only if the grade of TH (assessed by the LRP) corresponding to the subject is not already fulfilled.

Exclusion Criteria:

* 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
* Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy.
* Less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve)
* Severe obstructive symptoms
* Symptomatic intra-abdominal abscess
* Contraindication for MRI
* Isolated perianal disease without luminal location
* MRE images of poor quality, based on previously defined criteria

Primary outcomes:
measure: Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
timeFrame: Day 1
Secondary outcomes:
measure: Intra- and inter-observer variability of lesions observed per segment during MRE in CD
timeFrame: Day 1
measure: Intra- and inter-observer variability of depth and grade of global transmural healing in CD
timeFrame: Day 1
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
city: Amiens
country: France
facility: CHU Amiens-Picardie (site Sud)
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Haut-Lévêque
city: Boulogne-Billancourt
country: France
facility: APHP - Hôpital Ambroise Paré
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand - Hôpital d'Estaing
city: Colombes
country: France
facility: APHP - Hôpital Louis Mourier
city: Lille
country: France
facility: CHRU de Lille - Hôpital Claude Huriez
city: Limoges
country: France
facility: CHU Limoges Dupuytren
city: Marseille
country: France
facility: AP-HM - Hôpital Nord
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint Eloi
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice - Hôpital l'Archet II
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Carémeau
city: Paris
country: France
facility: APHP - Hôpital Européen Georges Pompidou (HEGP)
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint Etienne - Hôpital Nord
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy - Hôpitaux de Brabois
Study officials:
affiliation: CHU Limoge Dupuytren
name: Sophie GEYL
role: PRINCIPAL_INVESTIGATOR
References: