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

NCT ID: NCT01216514

Last Updated: 2011-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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 ".

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ROBLIN Xavier, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

Service de Gastro-entérologie

Saint-Etienne, , France

Countries

France

Other Identifiers

1008074

Identifier Type: -

Identifier Source: org_study_id