TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
Recruiting · NCT05903066 · Observational (researchers observe without assigning treatment) · Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
View the official record on ClinicalTrials.gov →Interventions studied
Magnetic Resonance Enterography (MRE)
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
18 locations listed.
- CHU Amiens-Picardie (site Sud) - Amiens, France
- CHU de Bordeaux - Hôpital Haut-Lévêque - Bordeaux, France
- APHP - Hôpital Ambroise Paré - Boulogne-Billancourt, France
- CHU de Clermont-Ferrand - Hôpital d'Estaing - Clermont-Ferrand, France
- APHP - Hôpital Louis Mourier - Colombes, France
- CHRU de Lille - Hôpital Claude Huriez - Lille, France
- CHU Limoges Dupuytren - Limoges, France
- CHU de Liège - Liège, Belgium
- AP-HM - Hôpital Nord - Marseille, France
- CHU de Montpellier - Hôpital Saint Eloi - Montpellier, France
- CHU de Nantes - Nantes, France
- CHU de Nice - Hôpital l'Archet II - Nice, France
- CHU de Nîmes - Hôpital Carémeau - Nîmes, France
- APHP - Hôpital Européen Georges Pompidou (HEGP) - Paris, France
- Hospices Civils de Lyon - Pierre-Bénite, France
- CHU Rennes - Hôpital Pontchaillou - Rennes, France
- CHU de Saint Etienne - Hôpital Nord - Saint-Priest-en-Jarez, France
- CHRU de Nancy - Hôpitaux de Brabois - Vandœuvre-lès-Nancy, France