Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT05903066

TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)

Led by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Updated on 2024-10-08

210

Participants Needed

18

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

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

CONDITIONS

Official Title

TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Diagnosed with Crohn's Disease for more than 6 months with histological confirmation available in medical records
  • Indication for Magnetic Resonance Enterography (MRE) based on routine clinical practice and validated by the treating physician
  • Receiving any Crohn's Disease treatment including biologicals or immunomodulators
  • Signed and dated written informed consent and privacy authorization prior to study start
  • Grade of transmural healing (TH) corresponding to the subject is not already fulfilled as assessed by local reader pair
Not Eligible

You will not qualify if you...

  • Pregnancy during the study
  • Unable to give consent due to physical or mental state
  • No written consent provided
  • Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease
  • Specific postsurgical settings such as ileoanal anastomosis, ileostomy, or colostomy
  • Fewer than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (excluding ileocecal valve)
  • Severe obstructive symptoms
  • Symptomatic intra-abdominal abscess
  • Contraindication for MRI
  • Isolated perianal disease without luminal location
  • Poor quality MRE images based on predefined criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

CHU de Liège

Liège, Belgium, 4000

Not Yet Recruiting

2

CHU Amiens-Picardie (site Sud)

Amiens, France, 80054

Actively Recruiting

3

CHU de Bordeaux - Hôpital Haut-Lévêque

Bordeaux, France, 33600

Not Yet Recruiting

4

APHP - Hôpital Ambroise Paré

Boulogne-Billancourt, France, 92100

Not Yet Recruiting

5

CHU de Clermont-Ferrand - Hôpital d'Estaing

Clermont-Ferrand, France, 63003

Actively Recruiting

6

APHP - Hôpital Louis Mourier

Colombes, France, 92700

Not Yet Recruiting

7

CHRU de Lille - Hôpital Claude Huriez

Lille, France, 59037

Not Yet Recruiting

8

CHU Limoges Dupuytren

Limoges, France, 87000

Actively Recruiting

9

AP-HM - Hôpital Nord

Marseille, France, 13015

Not Yet Recruiting

10

CHU de Montpellier - Hôpital Saint Eloi

Montpellier, France, 34295

Actively Recruiting

11

CHU de Nantes

Nantes, France, 44093

Not Yet Recruiting

12

CHU de Nice - Hôpital l'Archet II

Nice, France, 06200

Not Yet Recruiting

13

CHU de Nîmes - Hôpital Carémeau

Nîmes, France, 30029

Not Yet Recruiting

14

APHP - Hôpital Européen Georges Pompidou (HEGP)

Paris, France, 75908

Not Yet Recruiting

15

Hospices Civils de Lyon

Pierre-Bénite, France, 69475

Not Yet Recruiting

16

CHU Rennes - Hôpital Pontchaillou

Rennes, France, 35033

Not Yet Recruiting

17

CHU de Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, France, 42270

Not Yet Recruiting

18

CHRU de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, France, 54500

Not Yet Recruiting

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Research Team

S

Sophie GEYL

CONTACT

L

Laurent PEYRIN-BIROULET

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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