Serologic Markers for Inflammatory Bowel Disease During Clinical Forms With Weak or Strong Evolution Capacities

Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases 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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases

• Study Type: Observational
• Enrollment (Actual): 194

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Service de Gastro-entérologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

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 ".

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
definition of the unstable form of Crohn disease and RCH	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	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment effective : patient in clinical and endoscopic remission state	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.	day 1
corticodependant patient	A patient will be considered as corticodependant if he presents a push of IBD after decresase of the corticosteroid therapy on 2 occasions.	history and day 1
corticoresistant patient	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.	history and day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: ROBLIN Xavier, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 6, 2010
• First Posted (ESTIMATE): October 7, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 3, 2011
• Last Update Submitted That Met QC Criteria: November 2, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: ANCA; ASCA; crohn disease; immunological markers; chronic inflammatory bowel diseases; hemorrhagic rectocolitis; serological markers
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 1008074