Crohn's DiseaseNCT00769236
Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease
A study testing Blood sampling and biopsy and Biopsy and blood sampling in people with Crohn's Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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 )). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Blood sampling and biopsy and Biopsy and blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients reached by disease of crohn
- patients reached by hemorrhagic first side-colitis
Who cannot join
- Forms ileales or ano-périneales pure of disease of crohn
- indefinite colitis
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoire d'Immunologie - Hopital de la Conception
Marseille, 13005
About this study
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 )).
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Blood sampling and biopsy, Biopsy and blood sampling
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and biopsyOther
Biopsy and blood : Research for various antibodies
Biopsy and blood samplingOther
Biopsy and blood : research for various antibodies
Biopsy and blood samplingOther
Blood and biopsy : research for various antibodies
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients with crohn disease Receives: Other: Blood sampling and biopsy |
| 2 | Other | Patients reached by hemorrhagic first side-colitis Receives: Other: Biopsy and blood sampling |
| 3 | Other | Patients controls Receives: Other: Biopsy and blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (1)
Determine if the patients reached by disease of crohn not presenting ASCA in their serum represent one under group of disease of crohn
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Desplat-Jego, MD, Principal investigator, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769236
- Sponsor's protocol ID
- 2008-A00080-55
- Other IDs
- 2008-05
- Status last verified
- Aug 2014
- First submitted
- 8 Oct 2008
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bertin D, Grimaud JC, Lesavre N, Benelmouloud C, Desjeux A, Garcia S, Desplat-Jego S. Targeting tissular immune response improves diagnostic performance of anti-Saccharomyces cerevisiae antibodies (ASCA) in Crohn's disease. PLoS One. 2013 Nov 26;8(11):e80433. doi: 10.1371/journal.pone.0080433. eCollection 2013.
PubMed 24303014
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intestinal Secretion of Antibodies and Auto-antibodies Associated With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00769236
- Acronym / sponsor ID
- 2008-A00080-55
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Blood sampling and biopsyPatients with crohn disease |
| 2 | Other | Other: Biopsy and blood samplingPatients reached by hemorrhagic first side-colitis |
| 3 | Other | Other: Biopsy and blood samplingPatients controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients reached by disease of crohn
- patients reached by hemorrhagic first side-colitis
Key exclusion criteria (2 listed)
- Forms ileales or ano-périneales pure of disease of crohn
- indefinite colitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling and biopsyBiopsy and blood : Research for various antibodies | Other | 1 |
| Biopsy and blood samplingBiopsy and blood : research for various antibodies | Other | 2 |
| Biopsy and blood samplingBlood and biopsy : research for various antibodies | Other | 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 24303014Bertin D, Grimaud JC, Lesavre N, Benelmouloud C, Desjeux A, Garcia S, Desplat-Jego S. Targeting tissular immune response improves diagnostic performance of anti-Saccharomyces cerevisiae antibodies (ASCA) in Crohn's disease. PLoS One. 2013 Nov 26;8(11):e80433. doi: 10.1371/journal.pone.0080433. eCollection 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Desplat-Jego, MD principal investigator
Assistance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and biopsy and Biopsy and blood sampling in people with Crohn's Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.