Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort

NCT02502552 | Completed

• 1 other identifier: 1308018
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on clinical factors (disease extension, perianal involvement, need for surgery, use of immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and their combined use has a sensitivity and a specificity of about 85%. However, 10 other antibodies have been identified and recently evaluated individually in IBD and especially in pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These complementary tests improve the reliability of the diagnosis. In a previous cross-sectional work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of anti-glycan Abs and especially a correlation with a pejorative form of the disease both in Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.

Conditions

Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease

Keywords

Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease; anti-glycan antibodies; antibodies stability; mucosal healing; predictive markers

Outcome Measures

Primary Outcomes (1)

• immunological status

  Immunological status is defined by anti-glycan antibodies (ACCA, ALCA, AMCA, anti-chitin and anti-laminarin), ASCA and ANCA. Antibody will be positive if level is found higher than the threshold defined by the laboratory (technical threshold). An antibody will be defined as stable if its status remains positive during 3 years(above the detection limit given by the reference laboratory) or negative during 3 years (below the detection limit given by the reference laboratory). Conversely, the lack of stability during 3 years will be defined as the transition from a positive to a negative status or inversely.

  3 years after first evaluation

Secondary Outcomes (5)

• clinical remission

  3 years after first evaluation

• anti-Tumor Necrosis Factor (TNF) therapeutic response

  3 years after first evaluation

• Mucosal healing

  3 years after first evaluation

• Intestinal permeability

  3 years after first evaluation

• surgical resection

  3 years after first evaluation

Study Arms (1)

Inflammatory Bowel Disease

Inflammatory Bowel Disease patients followed in Saint-Etienne Hospital since 3 years or more. Blood specimen 3 years after a first blood specimen

Other: blood specimen

Interventions

blood specimen OTHER

blood specimen

Inflammatory Bowel Disease

Eligibility Criteria

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

Study Population

Ulcerative colitis and Crohn's disease patient followed in Saint-Etienne Hospital since 3 years or more

You may qualify if:

• Patients included in previous study (AOL 2010) and followed in our department, accepting blood sampling and stool analysis
• Written consent of the patient

You may not qualify if:

• Patient who decline to participate to the study
• Patient in the incapacity to give consent
• Patient deprived of their liberty by a judicial or administrative decision

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood specimen in IBD cohort of 195 patients followed in Saint-Etienne Hospital

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xavier Roblin, PhD

  CHU 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: July 16, 2015
• First Posted: July 20, 2015
• Study Start: November 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

FR (1)