Clinical trial NCT01216514: Serologic Markers for Inflammatory Bowel Disease During Clinical Forms With Weak or Strong Evolution Capacities
Official title: Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases During Clinical Forms With Weak or Strong Evolution Capacities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: chronic inflammatory bowel diseases
crohn disease
hemorrhagic rectocolitis
immunological markers
serological markers
ANCA
ASCA
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 194
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: community sample

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Major Patient
* IBD (RCH or MC) diagnosed according to the clinical, endoscopic and histological criteria
* Accepting the sampling of blood
* Patient member or legal successor of a national insurance scheme
* Taken care medical in the service of gastroenterology of CHU de Saint Etienne
* Patient having signed the form of consent

Exclusion Criteria:

* Minor Patient or uncapable
* Patient suffering from indefinite colitis
* Refusal of the sampling of blood
* Pregnant Woman
* Incapacity or refusal to sign the consent writes
* Subjects deprived of freedom by a court or administrative order
* Use of an anti-TNF. According to the indications ensuing from the Sonic trial or from the strategy " Top Down ".

Primary outcomes:
measure: definition of the unstable form of Crohn disease and RCH
timeFrame: day 1
Secondary outcomes:
measure: Treatment effective : patient in clinical and endoscopic remission state
timeFrame: day 1
measure: corticodependant patient
timeFrame: history and day 1
measure: corticoresistant patient
timeFrame: history and day 1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Service de Gastro-entérologie
Study officials:
affiliation: CHU de Saint-Etienne
name: ROBLIN Xavier, MD
role: PRINCIPAL_INVESTIGATOR
References: