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

NCT01216514 | Completed

• 1 other identifier: 1008074
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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

Keywords

chronic inflammatory bowel diseases; crohn disease; hemorrhagic rectocolitis; immunological markers; serological markers; ANCA; ASCA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Treatment effective : patient in clinical and endoscopic remission state

  day 1

• corticodependant patient

  history and day 1

• corticoresistant patient

  history and day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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

You may not qualify if:

• 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 ".

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Service de Gastro-entérologie

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Proctocolitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Proctitis; Colonic Diseases; Sigmoid Diseases; Rectal Diseases

Study Officials

• ROBLIN Xavier, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 3, 2011

Record last verified: 2011-11

Locations

FR (1)