Evaluating Transmural Healing in Crohn's Disease
TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study
This study is trying to see if a new way to measure healing in the intestines can help doctors better understand and treat patients with Crohn's Disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Academic / other |
| Drugs / interventions | infliximab, adalimumab, vedolizumab, ustekinumab, methotrexate |
| Locations | 18 sites (Liège and 17 other locations) |
| Trial ID | NCT05903066 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to establish an objective and reproducible system for assessing transmural healing in patients with Crohn's Disease (CD). It will involve 210 patients across 14 sites, with each site contributing 15 patients based on their grade of transmural healing as evaluated by a gastroenterologist and a radiologist. The primary endpoint focuses on defining the depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE). Additionally, the study will analyze the variability of radiological findings and definitions of transmural healing among observers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Crohn's Disease for more than six months.
Not a fit: Patients with ulcerative colitis, unclassified IBD, or specific postsurgical settings such as ileoanal anastomosis, ileostomy, or colostomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment and management of Crohn's Disease, enhancing treatment outcomes for patients.
How similar studies have performed: While this approach is novel in its specific focus on transmural healing definitions, similar studies in inflammatory bowel disease have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Liège and 17 other locations
- CHU de Liège — Liège, Belgium (Not_yet_recruiting)
- CHU Amiens-Picardie (site Sud) — Amiens, France (Recruiting)
- CHU de Bordeaux - Hôpital Haut-Lévêque — Bordeaux, France (Not_yet_recruiting)
- APHP - Hôpital Ambroise Paré — Boulogne-Billancourt, France (Not_yet_recruiting)
- CHU de Clermont-Ferrand - Hôpital d'Estaing — Clermont-Ferrand, France (Recruiting)
- APHP - Hôpital Louis Mourier — Colombes, France (Not_yet_recruiting)
- CHRU de Lille - Hôpital Claude Huriez — Lille, France (Not_yet_recruiting)
- CHU Limoges Dupuytren — Limoges, France (Recruiting)
- AP-HM - Hôpital Nord — Marseille, France (Not_yet_recruiting)
- CHU de Montpellier - Hôpital Saint Eloi — Montpellier, France (Recruiting)
- CHU de Nantes — Nantes, France (Not_yet_recruiting)
- CHU de Nice - Hôpital l'Archet II — Nice, France (Not_yet_recruiting)
- CHU de Nîmes - Hôpital Carémeau — Nîmes, France (Not_yet_recruiting)
- APHP - Hôpital Européen Georges Pompidou (HEGP) — Paris, France (Not_yet_recruiting)
- Hospices Civils de Lyon — Pierre-Bénite, France (Not_yet_recruiting)
- CHU Rennes - Hôpital Pontchaillou — Rennes, France (Not_yet_recruiting)
- CHU de Saint Etienne - Hôpital Nord — Saint-Priest-en-Jarez, France (Not_yet_recruiting)
- CHRU de Nancy - Hôpitaux de Brabois — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Sophie GEYL — CHU Limoge Dupuytren
- Study coordinator: Sophie GEYL
- Email: sophie.geyl@chu-limoges.fr
- Phone: +33 5 55 05 66 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.