Sponsor study identifier
observational
144
1 country
3
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 2014
Actual (reported)April 2014
Actual (reported)July 20, 2015
Actual (reported)July 21, 2015
Actual (reported)Correlation between new immunological markers rate and Crohn's Disease relapse
This outcome will help us to show that regular monitoring of new immunological markers (serum markers of cytotoxicity of lymphocytes, pro- and anti-inflammatory cytokines and urinary and fecal neopterin) let us predict relapse of the disease
within 15 months
Correlation between usual immunological markers rate and Crohn's Disease relapse
within 15 months
patients will have biological samplings (blood, urine and faecal sampling) and will fill questionnaires to assess their stress and adaptation
Blood, urine and faecal sampling every 3 months
patients fill several questionnaires every month to assess stress and adaptation parameters
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with Crohn Disease
CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie
Clermont-Ferrand, 63000, France
Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Hépato-Gastroentérologie
Pierre-Bénite, 69495, France
CHU Hôpital Nord - Service d'Hépato-Gastroentérologie
Saint-Etienne, 42055, France
144 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2015
First Posted
July 21, 2015
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease
Contact the study team to confirm eligibility.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
July 24, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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