Postoperative REcurrence and DynamICs of T Cell Subsets in Crohn's Disease (PREDICT)
Primary Purpose
Crohn Disease
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn Disease
Eligibility 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
Sites / Locations
- Service d'Hépato-Gastroentérologie Centre hospitalier Lyon Sud Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Postoperative endoscopic recurrence
Arm Description
Patients with a diagnosis of Crohn's disease who undergo an ileo-colonic curative resection
Outcomes
Primary Outcome Measures
Postoperative endoscopic recurrence, assessed by a Rutgeerts 's score > i1, over the one-year post-surgery follow-up
Rutgeerts 's score > i1
Secondary Outcome Measures
proportion of T cell subsets in the arm of patients who will experience a recurrence and those who will not.
number of T cell subsets in the arm of patients who will experience a recurrence and those who will not.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02770495
Brief Title
Postoperative REcurrence and DynamICs of T Cell Subsets in Crohn's Disease
Acronym
PREDICT
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postoperative endoscopic recurrence
Arm Type
Experimental
Arm Description
Patients with a diagnosis of Crohn's disease who undergo an ileo-colonic curative resection
Intervention Type
Other
Intervention Name(s)
blood sample
Primary Outcome Measure Information:
Title
Postoperative endoscopic recurrence, assessed by a Rutgeerts 's score > i1, over the one-year post-surgery follow-up
Description
Rutgeerts 's score > i1
Time Frame
at one year
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane NANCEY, MD
Organizational Affiliation
Service d'Hépato-Gastroentérologie Centre hospitalier Lyon Sud Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hépato-Gastroentérologie Centre hospitalier Lyon Sud Hospices Civils de Lyon
City
Pierre Benite
Country
France
12. IPD Sharing Statement
Learn more about this trial
Postoperative REcurrence and DynamICs of T Cell Subsets in Crohn's Disease
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