Crohn DiseaseTRENCH 1NCT05903066
TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
An observational study of Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 13 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Magnetic Resonance Enterography (MRE)
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 28 Sep 2023to 19 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- ≥ 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
France12 sites
CHU Amiens-Picardie (site Sud)
Amiens, 80054
CHU de Bordeaux - Hôpital Haut-Lévêque
Bordeaux, 33600
APHP - Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
CHU de Clermont-Ferrand - Hôpital d'Estaing
Clermont-Ferrand, 63003
CHRU de Lille - Hôpital Claude Huriez
Lille, 59037
CHU Limoges Dupuytren
Limoges, 87000
AP-HM - Hôpital Nord
Marseille, 13015
CHU de Montpellier - Hôpital Saint Eloi
Montpellier, 34295
CHU de Nantes
Nantes, 44093
CHU de Nîmes - Hôpital Carémeau
Nîmes, 30029
Hospices Civils de Lyon
Pierre-Bénite, 69475
CHU Rennes - Hôpital Pontchaillou
Rennes, 35033
About this study
Official title: TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study
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
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Magnetic Resonance Enterography (MRE)
- Keywords
- IBD, CD
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Enterography (MRE)Procedure or 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start28 Sep 2023
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie GEYL, Principal investigator, CHU Limoge Dupuytren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903066
- Sponsor's protocol ID
- GETAID-2022-03
- Acronym
- TRENCH 1
- Status last verified
- Nov 2026
- First submitted
- 5 Jun 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study
- ClinicalTrials.gov ID
- NCT05903066
- Acronym / sponsor ID
- TRENCH 1 / GETAID-2022-03
- Conditions
- Crohn Disease
- Keywords
- IBD, CD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Enterography (MRE)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. | Procedure or surgery | – |
Primary outcome
Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Time frame: Day 1
An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.
2 secondary outcomes
Intra- and inter-observer variability of lesions observed per segment during MRE in CD
Time frame: Day 1
Intra- and inter-observer variability of depth and grade of global transmural healing in CD
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie GEYL principal investigator
CHU Limoge Dupuytren
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.