Crohn'sRecruiting
TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
Observational · No treatment assigned · 18 sites · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- ≥ 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
Plus 3 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 210 participants are expected to take part.
- Start date: 2023-09-28.
- Main results expected around 2025-07 (estimate from the record).
- 18 study sites listed (4 marked recruiting) in Belgium and France.
Main thing being measured
- Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD (Day 1)
In the researchers’ words
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
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Enrollment | 210 (estimated) |
| Start date | 2023-09-28 |
| Primary completion (est.) | 2025-07 |
| First posted | 2023-06-15 |
| Last updated | 2024-10-08 |
| Official title | TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study |
| ClinicalTrials.gov ID | NCT05903066 |
Interventions
- Magnetic Resonance Enterography (MRE) (Procedure)
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.
Full eligibility criteria (from the record)
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
Locations (18)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.