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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01216514
First received: October 4, 2010
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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.


Condition
Inflammatory Bowel Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases During Clinical Forms With Weak or Strong Evolution Capacities

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • definition of the unstable form of Crohn disease and RCH [ Time Frame: day 1 ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Treatment effective : patient in clinical and endoscopic remission state [ Time Frame: day 1 ] [ Designated as safety issue: No ]

    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.

  • corticodependant patient [ Time Frame: history and day 1 ] [ Designated as safety issue: No ]
    A patient will be considered as corticodependant if he presents a push of IBD after decresase of the corticosteroid therapy on 2 occasions.

  • corticoresistant patient [ Time Frame: history and day 1 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 194
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

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 ".
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216514

Locations
France
Service de Gastro-entérologie
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: ROBLIN Xavier, MD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01216514     History of Changes
Other Study ID Numbers: 1008074
Study First Received: October 4, 2010
Last Updated: November 2, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
chronic inflammatory bowel diseases
crohn disease
hemorrhagic rectocolitis
immunological markers
serological markers
ANCA
ASCA

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on September 18, 2014