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

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ClinicalTrials.gov Identifier: NCT02770495
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Crohn Disease Other: blood sample Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamics of Regulatory and Effector T Lymphocyte Subsets in Patients With Crohn's Disease During Postoperative Recurrence : Implications for Identifying Patients at High Risk of Relapse.
Study Start Date : January 2011
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Postoperative endoscopic recurrence
Patients with a diagnosis of Crohn's disease who undergo an ileo-colonic curative resection
Other: blood sample



Primary Outcome Measures :
  1. Postoperative endoscopic recurrence, assessed by a Rutgeerts 's score > i1, over the one-year post-surgery follow-up [ Time Frame: at one year ]
    Rutgeerts 's score > i1


Secondary Outcome Measures :
  1. proportion of T cell subsets in the arm of patients who will experience a recurrence and those who will not. [ Time Frame: at 3 months before relapse ]
  2. number of T cell subsets in the arm of patients who will experience a recurrence and those who will not. [ Time Frame: at 3 months before relapse ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770495


Locations
France
Service d'Hépato-Gastroentérologie Centre hospitalier Lyon Sud Hospices Civils de Lyon
Pierre Benite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Stéphane NANCEY, MD Service d'Hépato-Gastroentérologie Centre hospitalier Lyon Sud Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02770495     History of Changes
Other Study ID Numbers: 2010-616
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes