Postoperative REcurrence and DynamICs of T Cell Subsets in Crohn's Disease

Phase 3

Completed

• Conditions: Crohn Disease
• Interventions: Other: blood sample

• Registration Number: NCT02770495
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

It is assumed that gut inflammation and lesions characterizing flares of Crohn's disease (CD) result from an aberrant T-cell mediated immune responses characterized by a complex balance between peripheral and lamina propria regulatory and effector T cell subsets. Because most of CD patients who undergo a surgery experienced a postoperative endoscopic recurrence of the disease (70 % at one year) leading to a clinical recurrence (10 % per year), the "model" of postoperative recurrence in CD represents a privileged situation that mimicks what happens in the gut of CD patients in clinical remission before the occurrence of further flares. It is likely that the same factors which underlie the immunopathogenesis of CD at its early stages also contribute to disease recurrence in the postoperative setting. Indeed, the postoperative state is performed for intent of disease remission and this situation represents probably an ideal setting to investigate the dynamics of most of T cell subsets in the peripheral and mucosal compartments because one may argue that removal of the diseased segment of bowel resets the disease to its earliest phases, providing an interesting window to better understand which T cell subsets predispose to disease recurrence.

That is the reason why this model will be used in the present project i) to understand better the immunopathogenesis of CD relapse; ii) to identify novel and promising immune cell-associated biomarkers capable to predict relapse of the disease and finally iii) to identify potential specific therapeutic target associated with T cell subsets involved in the initiation of disease.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-10
• Last Update Submitted: 2016-05-10
• Study First Posted: 2016-05-12
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Aged over 18 years
• Men or non-pregnant women
• Patients with a diagnosis of Crohn's disease who undergo an ileo-colonic curative resection
• No change of the postoperative treatment before assessing an endoscopic recurrence during the one-year post surgery follow-up period
• Informed consent given

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Exclusion Criteria

• Pregnancy
• History of disease, including mental/emotional disorder, that might interfere with their participation in the study
• Inability to comply with the protocol requirements
• Inability to fill in the diary cards

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Postoperative endoscopic recurrence	blood sample	Patients with a diagnosis of Crohn's disease who undergo an ileo-colonic curative resection

Primary Outcome Measures

Name	Time	Method
Postoperative endoscopic recurrence, assessed by a Rutgeerts 's score > i1, over the one-year post-surgery follow-up	at one year	Rutgeerts 's score \> i1

Secondary Outcome Measures

Name	Time	Method
proportion of T cell subsets in the arm of patients who will experience a recurrence and those who will not.	at 3 months before relapse
number of T cell subsets in the arm of patients who will experience a recurrence and those who will not.	at 3 months before relapse

Trial Locations

Locations (1)

Service d'Hépato-Gastroentérologie Centre hospitalier Lyon Sud Hospices Civils de Lyon; 🇫🇷 Pierre Benite, France