Serologic Markers for Inflammatory Bowel Disease During Clinical Forms With Weak or Strong Evolution Capacities
Factors forecast Chronic Inflammatory Bowel Diseases (IBD) remain at present essentially on clinical factors (extension of the disease, achievement of the perianal ring, requirement of surgery, treatment by immunomodulators…). All IBD specific immunological or serological markers showed only a diagnostic role for indefinite colitis (hemorrhagic Rectocolitis vs Crohn Disease) but were never able to be considered as predictive elements of adults IBD evolution. Among the most used, the presence of ANCA's antibody and ASCA allows to separate hemorrhagic rectocolitis (ANCA + / ASCA-) from Crohn disease (ANCA-/ASCA +) and their combination present an average sensibility about 85 % and a 85 % specificity. However, 8 other antibody types were recently isolated and estimated individually during IBD in particular during child Crohn diseases (anti-OmpC, anti-I2, anti-CBir1, anti-glycans (ALCA, AMCA and ACCA) anti-Goblet cells and albicans Candida's specific anti-mannan). These complementary assays improve significantly the reliability of the diagnosis. However, if the use of these new markers has an indisputable diagnostic role, their predictive role in the evolution of IBD was estimated at the adult's only rarely during Crohn diseases. Consequently, the investigators suggest realizing an exhaustive analysis of all these new immunological markers to define, if their association can have an interest in the differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary) clinical forms.
Inflammatory Bowel Diseases
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases During Clinical Forms With Weak or Strong Evolution Capacities|
- definition of the unstable form of Crohn disease and RCH [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Crohn disease, at least one of the following criteria:
Use of anti-TNF antibody in case of immunosuppressor failure. Surgery of resection (at least two resections or more than 70 cms of intestinal resections) Anoperineal form with complex fistulas Spread intestinal affection Beginning of the disease before 16 years
RCH, at least one of the following criteria:
Initial pancolite affection Immunosuppresseur use in the first year of evolution Use of anti-TNF Severe Colitis
- Treatment effective : patient in clinical and endoscopic remission state [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Treatment will be considered as effective if the patient is in clinical and endoscopic remission state.
A patient will be considered in clinical remission if he presents:
- A CDAI score (Crohn disease activity index) lower than 150 for the MC;
- A MAYO score lower than 2 or a score of Lichtiger lower than 4 for RCH.
A patient will be considered in endoscopic remission if he presents:
- A Lichtiger score lower than 4 for the MC;
- An endoscopic MAYO score lower than 2 for RCH.
- corticodependant patient [ Time Frame: history and day 1 ] [ Designated as safety issue: No ]A patient will be considered as corticodependant if he presents a push of IBD after decresase of the corticosteroid therapy on 2 occasions.
- corticoresistant patient [ Time Frame: history and day 1 ] [ Designated as safety issue: No ]A patient will be considered as corticoresistant if his disease remains active for a threshold of corticosteroid therapy of at least 40 mg/day of Prednisolone and on a duration of 4 weeks.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||October 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216514
|Service de Gastro-entérologie|
|Saint-Etienne, France, 42055|
|Principal Investigator:||ROBLIN Xavier, MD||CHU de Saint-Etienne|