Skip to main content
OpenTrials
Completed

NCT Number: NCT02770495

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service d'Hépato-Gastroentérologie Centre hospitalier Lyon Sud Hospices Civils de Lyon

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Acronym: PREDICT

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.