Flammatory Bowel DiseaseNCT01663142
Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM
An observational study of Flammatory Bowel Disease and Crohn's Disease, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood. This disease, due to its morbidity and mortality, poses a significant public health problem in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flammatory Bowel Disease, Crohn's Disease
- How many people
- 230 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2010to Dec 2017
- 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: Sick to benefit from ileal, colonic or ileocolic continuity with re Cohn proved a complicated disease (stenosis or fistula) or resistant to medical treatment well led
Who may be able to join
- Sick in whom endoscopic control six months after surgery is needed to assess the presence and severity of endoscopic recurrence in order to alter the medical management.
- Persons affiliated to the Social Security
- Persons who have signed informed consent
Who cannot join
- Patient not affiliated to social security
- Pregnant Women
- Persons participating in other clinical trials
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Grenoble
Grenoble, 38043
AP-HM
Marseille, 13354
CHU de Montpellier
Montpellier, 34295
CHU de Nice
Nice, 06202
About this study
Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood. This disease, due to its morbidity and mortality, poses a significant public health problem in France. Apart from the involvement of bacterial factors and those involving the permeability of the epithelial barrier, it is now well recognized that several factors are associated with genetic predisposition in some of these patients. Among these factors, the Nod2 mutations were first identified. Studies concerning the presence of these mutations and the severity of disease results were sometimes conflicting. Very recently, new interesting mutations in genes involved in autophagy were found with greater frequency in patients with Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly shown on large patient cohorts,the IRGM polymorphism was associated with a progressive disease, with histological severity scores. One of the severity criteria of Crohn's disease is the early recurrence observed in some patients after surgical resection of the injured segment. Predictive factors for such recurrence after surgery are not known or not.
- Conditions
- Flammatory Bowel Disease, Crohn's Disease
- Keywords
- Crohn's disease, gastrointestinal tract
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who receive surgical resection for intestinal in CD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Search for IRGM mutations and compare the frequency of these mutations.
Patients who receive surgical resection for intestinal MC have, within six months after surgery gastrointestinal endoscopy for judging the endoscopic recurrence and modify treatment if necessary. This quantifies the endoscopic recurrence of i0 to i4 classified according to the Rutgeerts score (45). Patients who have a score ≥ i2 have a severe endoscopic recurrence. We will compare the prevalence of sick with a score ≥ i2 in patient groups with or without mutation in the gene IRGM. The investigators will look for the existence of a mutation in the gene IRGM, Atg16 and IL23R. The mutation in the gene IRGM being the main prognostic factor, mutations in the genes IL23R Atg16 and prognostic factors constituting secondary.
Measured: 6 months post surgery
Secondary outcomes (3)
To assess the prevalence of mutations IGRM in a prospective series of 200 patients operated
The prevalence of mutations IGRM, Atg16 and IL23 will be determined
Measured: 6 months post surgery
Determine whether there are phenotypic characteristics of the disease associated with mutations of IGRM
The investigators will compare the frequency of postoperative recurrence in patients who have a mutation in the genes IL23 and Atg16
Measured: 6 months post surgery
Determine whether there are pathological features associated with mutations of IGRM.
The investigators will determine if the main phenotypic characteristics of CD (age of onset, time between diagnosis and surgery, use of immunosuppressive and biologic therapies, smoking localization of the disease, etc..) Are associated with increased prevalence of mutations of IGRM, Atg16 and IL23R.
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flammatory Bowel DiseaseStudies 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier HEBUTERNE, PU-PH, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663142
- Sponsor's protocol ID
- 09-API-02
- Status last verified
- May 2010
- First submitted
- 6 Aug 2012
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM
- ClinicalTrials.gov ID
- NCT01663142
- Acronym / sponsor ID
- 09-API-02
- Conditions
- Flammatory Bowel Disease, Crohn's Disease
- Keywords
- Crohn's disease, gastrointestinal tract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Aug 2012 (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.
Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood. This disease, due to its morbidity and mortality, poses a significant public health problem in France. Apart from the involvement of bacterial factors and those involving the permeability of the epithelial barrier, it is now well recognized that several factors are associated with genetic predisposition in some of these patients. Among these factors, the Nod2 mutations were first identified. Studies concerning the presence of these mutations and the severity of disease results were sometimes conflicting. Very recently, new interesting mutations in genes involved in autophagy were found with greater frequency in patients with Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly shown on large patient cohorts,the IRGM polymorphism was associated with a progressive disease, with histological severity scores. One of the severity criteria of Crohn's disease is the early recurrence observed in some patients after surgical resection of the injured segment. Predictive factors for such recurrence after surgery are not known or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who receive surgical resection for intestinal in CD | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sick to benefit from ileal, colonic or ileocolic continuity with re Cohn proved a complicated disease (stenosis or fistula) or resistant to medical treatment well led
Key inclusion criteria (3 listed)
- Sick in whom endoscopic control six months after surgery is needed to assess the presence and severity of endoscopic recurrence in order to alter the medical management.
- Persons affiliated to the Social Security
- Persons who have signed informed consent
Key exclusion criteria (3 listed)
- Patient not affiliated to social security
- Pregnant Women
- Persons participating in other clinical trials
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
Search for IRGM mutations and compare the frequency of these mutations.
Time frame: 6 months post surgery
Patients who receive surgical resection for intestinal MC have, within six months after surgery gastrointestinal endoscopy for judging the endoscopic recurrence and modify treatment if necessary. This quantifies the endoscopic recurrence of i0 to i4 classified according to the Rutgeerts score (45). Patients who have a score ≥ i2 have a severe endoscopic recurrence. We will compare the prevalence of sick with a score ≥ i2 in patient groups with or without mutation in the gene IRGM. The investigators will look for the existence of a mutation in the gene IRGM, Atg16 and IL23R. The mutation in the gene IRGM being the main prognostic factor, mutations in the genes IL23R Atg16 and prognostic factors constituting secondary.
3 secondary outcomes
To assess the prevalence of mutations IGRM in a prospective series of 200 patients operated
Time frame: 6 months post surgery
Determine whether there are phenotypic characteristics of the disease associated with mutations of IGRM
Time frame: 6 months post surgery
Determine whether there are pathological features associated with mutations of IGRM.
Time frame: 6 months post surgery
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 26 Jan 2024.
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.
Xavier HEBUTERNE, PU-PH study director
Centre Hospitalier Universitaire de Nice
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flammatory Bowel Disease and Crohn's Disease, run by Centre Hospitalier Universitaire de Nice at 4 sites 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 3 inclusion and 3 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Search for IRGM mutations and compare the frequency of these mutations. (time frame: 6 months post surgery). 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 26 Jan 2024.