- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00769236
Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease
May 4, 2026 updated by: Assistance Publique Hopitaux De Marseille
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 )).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France, 13005
- Laboratoire d'Immunologie - Hopital de la Conception
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1
Patients with crohn disease
|
Biopsy and blood : Research for various antibodies
|
|
Other: 2
Patients reached by hemorrhagic first side-colitis
|
Biopsy and blood : research for various antibodies
Blood and biopsy : research for various antibodies
|
|
Other: 3
Patients controls
|
Biopsy and blood : research for various antibodies
Blood and biopsy : research for various antibodies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sophie Desplat-Jego, MD, Assistance Publique Des Hopitaux de Marseille
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
October 8, 2008
First Submitted That Met QC Criteria
October 8, 2008
First Posted (Estimated)
October 9, 2008
Study Record Updates
Last Update Posted (Actual)
May 7, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Inflammatory Bowel Diseases
- Crohn Disease
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Cytological Techniques
- Cytodiagnosis
- Diagnostic Techniques, Surgical
- Biopsy
- Blood Specimen Collection
Other Study ID Numbers
- 2008-A00080-55
- 2008-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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