Clinical trial NCT02504255: Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease
Official title: Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Keywords: Crohn disease
inflammatory biomarkers
immunologic markers
calprotectin
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn Disease

Brief summary: Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable remission. the probability of recurrence of CD in a patient in remission is even stronger if it pre-exists endoscopic lesions of the intestinal mucosa.

The mucosal healing exploration needs the realization of an ileo-colonoscopy under general anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its too frequent repetition. we do not currently have noninvasive and reliable markers able to predict the occurrence of thrust of CD and allow the introduction of a more suitable treatment.

Indeed, relapse prevention is the best way to avoid complications and formation of lesions that lead to the irreversible medical treatment failure and surgery.

Since during the CD, it is the immunological changes that lead to inflammation and lesions, we make the assumption that the ability of certain markers immunological to predict a relapse of CD is higher than that of other in particular inflammatory markers.

This work should help to identify the profile of patients with CD in remission but at high risk of recurrence. It will specify i) the potential new markers immunological, from the pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally, the stress and the management of stressful events in the occurrence of a relapse.

This work also will specify the evolution of different markers at the moment of thrust


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years.
* Patient with CD previously diagnosed according to standard criteria.
* Patient remission (HBS≤4) for at least 3 months and has not received corticosteroids (including budesonide) in the 3 months before.
* Patient without concomitant treatment of Crohn's disease or as stable dose (5-ASA, corticosteroids, immunosuppressants, anti-TNF) immunosuppressants (azathioprine, Purinethol, methotrexate) and / or anti-TNF and / or 5- amino salicylates (5-ASA) for at least 6 months.
* Patient who signed a consent.
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* A patient with an active CD (HB score≥5).
* Patient who relapsed in the previous three months before inclusion.
* Patient who received corticosteroids (including budesonide) in the 6 months prior to inclusion.
* Patients on stable dose of non-anti-TNF in the 6 months prior to inclusion.
* Patient taking nonsteroidal anti-inflammatory drugs or antibiotics.
* Patient with complications of intestinal sub-occlusion type fistulas or abdominal abscesses.
* Patient with exclusive perianal disease or a predominate perianal manifestation.
* Pregnant women (examination).
* Patient who is the subject of extensive intestinal resection (\> 1 m).
* Patient with ileostomy or colostomy.
* Patient on legal protection measure or who does not have the legal capacity to consent
* Lack of signed written consent of the patient.-

Primary outcomes:
measure: Correlation between new immunological markers rate and Crohn's Disease relapse
timeFrame: within 15 months
Secondary outcomes:
measure: Correlation between usual immunological markers rate and Crohn's Disease relapse
timeFrame: within 15 months
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Hépato-Gastroentérologie
city: Saint-etienne
country: France
facility: CHU Hôpital Nord - Service d'Hépato-Gastroentérologie
Study officials:
References: