Inflammatory Bowel DiseasesNCT01216514
Serologic Markers for Inflammatory Bowel Disease During Clinical Forms With Weak or Strong Evolution Capacities
An observational study of Inflammatory Bowel Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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…). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 194 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Jul 2011
- Phase
- Observational
- 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
Study population: community sample
Who may be able to join
- 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
Who cannot join
- 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 ".
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases During Clinical Forms With Weak or Strong Evolution Capacities
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.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- chronic inflammatory bowel diseases, crohn disease, hemorrhagic rectocolitis, immunological markers, serological markers, ANCA, ASCA
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Proctocolitis
What is being measured
The primary outcome is the main question the study is designed to answer.
definition of the unstable form of Crohn disease and RCH
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
Measured: day 1
Secondary outcomes (3)
Treatment effective : patient in clinical and endoscopic remission state
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.
Measured: day 1
corticodependant patient
A patient will be considered as corticodependant if he presents a push of IBD after decresase of the corticosteroid therapy on 2 occasions.
Measured: history and day 1
corticoresistant patient
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.
Measured: history and day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROBLIN Xavier, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216514
- Sponsor's protocol ID
- 1008074
- Status last verified
- Nov 2011
- First submitted
- 4 Oct 2010
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases During Clinical Forms With Weak or Strong Evolution Capacities
- ClinicalTrials.gov ID
- NCT01216514
- Acronym / sponsor ID
- 1008074
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- chronic inflammatory bowel diseases, crohn disease, hemorrhagic rectocolitis, immunological markers, serological markers, ANCA, ASCA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Oct 2010 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
definition of the unstable form of Crohn disease and RCH
Time frame: day 1
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
3 secondary outcomes
Treatment effective : patient in clinical and endoscopic remission state
Time frame: day 1
corticodependant patient
Time frame: history and day 1
corticoresistant patient
Time frame: history and day 1
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 3 Nov 2011.
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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.
ROBLIN Xavier, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Centre Hospitalier Universitaire de Saint Etienne 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 6 inclusion and 7 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 3 Nov 2011. 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?
definition of the unstable form of Crohn disease and RCH (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2011.