Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling and biopsy
Biopsy and blood sampling
Biopsy and blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- Patients reached by disease of crohn
- patients reached by hemorrhagic first side-colitis
Exclusion Criteria:
- Forms ileales or ano-périneales pure of disease of crohn
- indefinite colitis
Sites / Locations
- Laboratoire d'Immunologie - Hopital de la Conception
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
1
2
3
Arm Description
Patients with crohn disease
Patients reached by hemorrhagic first side-colitis
Patients controls
Outcomes
Primary Outcome Measures
Compare the performances of the dosage of the ASCA in floating it of culture of intestinal biopsies in that of their dosage in the serum
Secondary Outcome Measures
Determine if the patients reached by disease of crohn not presenting ASCA in their serum represent one under group of disease of crohn
Full Information
NCT ID
NCT00769236
First Posted
October 8, 2008
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT00769236
Brief Title
Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease
Official Title
Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We propose to study the intestinal secretion of ASCA by evaluating them in biopsy culture supernatants from a cohort of patients suffering from CD (n=80) and a cohort of control patients (UC (n=40) and patients without IBD (n=40 )).
Detailed Description
Its diagnosis is based upon clinical, endoscopic and histological parameters but recent studies have shown that seric evaluation of immunological markers (anti-Saccharomyces cerevisiae antibodies (ASCA), anti-neutrophil cytoplasmic auti-antibodies (ANCA)) could be useful. Crohn's disease (CD) is an inflammatory bowel disease (IBD) of the young people. Antibodies anti-chitobisoside carbohydrate (ACCA), anti-laminaribioside carbohydrate (ALCA) and anti-mannobioside carbohydrate (AMCA) have been described as new serological markers of CD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Patients with crohn disease
Arm Title
2
Arm Type
Other
Arm Description
Patients reached by hemorrhagic first side-colitis
Arm Title
3
Arm Type
Other
Arm Description
Patients controls
Intervention Type
Other
Intervention Name(s)
Blood sampling and biopsy
Intervention Description
Biopsy and blood : Research for various antibodies
Intervention Type
Other
Intervention Name(s)
Biopsy and blood sampling
Intervention Description
Biopsy and blood : research for various antibodies
Intervention Type
Other
Intervention Name(s)
Biopsy and blood sampling
Intervention Description
Blood and biopsy : research for various antibodies
Primary Outcome Measure Information:
Title
Compare the performances of the dosage of the ASCA in floating it of culture of intestinal biopsies in that of their dosage in the serum
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Determine if the patients reached by disease of crohn not presenting ASCA in their serum represent one under group of disease of crohn
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients reached by disease of crohn
patients reached by hemorrhagic first side-colitis
Exclusion Criteria:
Forms ileales or ano-périneales pure of disease of crohn
indefinite colitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Desplat-Jego, MD
Organizational Affiliation
Assistance Publique des Hopitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire d'Immunologie - Hopital de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
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Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease
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