Image

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

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

Recruiting
18-75 years
All
Phase N/A

Powered by AI

Overview

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

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.

Eligibility

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

Study details
    Crohn Disease

NCT05903066

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.