Crohn DiseaseNCT02504255
Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease
An observational study of Crohn Disease, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable remission. the probability of recurrence of CD in a patient in remission is even stronger if it pre-exists endoscopic lesions of the intestinal mucosa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Biological samplings and Questionnaires
- How many people
- 144 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2011to Apr 2014
- 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: Patients with Crohn Disease
Who may be able to join
- Patient over 18 years.
- Patient with CD previously diagnosed according to standard criteria.
- Patient remission (HBS≤4) for at least 3 months and has not received corticosteroids (including budesonide) in the 3 months before.
- Patient without concomitant treatment of Crohn's disease or as stable dose (5-ASA, corticosteroids, immunosuppressants, anti-TNF) immunosuppressants (azathioprine, Purinethol, methotrexate) and / or anti-TNF and / or 5- amino salicylates (5-ASA) for at least 6 months.
- Patient who signed a consent.
- Patient affiliated to a social security scheme.
Who cannot join
- A patient with an active CD (HB score≥5).
- Patient who relapsed in the previous three months before inclusion.
- Patient who received corticosteroids (including budesonide) in the 6 months prior to inclusion.
- Patients on stable dose of non-anti-TNF in the 6 months prior to inclusion.
- Patient taking nonsteroidal anti-inflammatory drugs or antibiotics.
- Patient with complications of intestinal sub-occlusion type fistulas or abdominal abscesses.
Show all 12Show fewer
- Patient with exclusive perianal disease or a predominate perianal manifestation.
- Pregnant women (examination).
- Patient who is the subject of extensive intestinal resection (> 1 m).
- Patient with ileostomy or colostomy.
- Patient on legal protection measure or who does not have the legal capacity to consent
- Lack of signed written consent of the patient.-
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie
Clermont-Ferrand, 63000
Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Hépato-Gastroentérologie
Pierre-Bénite, 69495
CHU Hôpital Nord - Service d'Hépato-Gastroentérologie
Saint-Etienne, 42055
About this study
Official title: Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter Cohort
Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable remission. the probability of recurrence of CD in a patient in remission is even stronger if it pre-exists endoscopic lesions of the intestinal mucosa.
The mucosal healing exploration needs the realization of an ileo-colonoscopy under general anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its too frequent repetition. we do not currently have noninvasive and reliable markers able to predict the occurrence of thrust of CD and allow the introduction of a more suitable treatment.
Read more
Indeed, relapse prevention is the best way to avoid complications and formation of lesions that lead to the irreversible medical treatment failure and surgery.
Since during the CD, it is the immunological changes that lead to inflammation and lesions, we make the assumption that the ability of certain markers immunological to predict a relapse of CD is higher than that of other in particular inflammatory markers.
This work should help to identify the profile of patients with CD in remission but at high risk of recurrence. It will specify i) the potential new markers immunological, from the pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally, the stress and the management of stressful events in the occurrence of a relapse.
This work also will specify the evolution of different markers at the moment of thrust
- Conditions
- Crohn Disease
- Being tested
- Biological samplings, Questionnaires
- Keywords
- Crohn disease, inflammatory biomarkers, immunologic markers, calprotectin
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingsBiological
Blood, urine and faecal sampling every 3 months
QuestionnairesOther
patients fill several questionnaires every month to assess stress and adaptation parameters
| Study group | Role | What they receive |
|---|---|---|
| Patients with Crohn's Disease | patients will have biological samplings (blood, urine and faecal sampling) and will fill questionnaires to assess their stress and adaptation Receives: Biological: Biological samplings; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between new immunological markers rate and Crohn's Disease relapse
This outcome will help us to show that regular monitoring of new immunological markers (serum markers of cytotoxicity of lymphocytes, pro- and anti-inflammatory cytokines and urinary and fecal neopterin) let us predict relapse of the disease
Measured: within 15 months
Secondary outcomes (1)
Correlation between usual immunological markers rate and Crohn's Disease relapse
This outcome will help us to test the ability of inflammatory markers which are already routinely used for diagnostic purposes to predict relapse of CD. These "usual" markers are : fecal calprotectin and lactoferrin, serum ultrasensitive C-Reactive Protein (CRP) and erythrocyte sedimentation rate (ESR)) is being evaluated (serum S100A12 protein, fecal, alpha-1-glycoprotein (orosomucoid) alpha-2 globulin)
Measured: within 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startApr 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504255
- Sponsor's protocol ID
- 2010.630
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter Cohort
- ClinicalTrials.gov ID
- NCT02504255
- Acronym / sponsor ID
- 2010.630
- Conditions
- Crohn Disease
- Keywords
- Crohn disease, inflammatory biomarkers, immunologic markers, calprotectin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Jul 2015 (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 disease (CD) usually evolves by surges interspersed by periods of unpredictable remission. the probability of recurrence of CD in a patient in remission is even stronger if it pre-exists endoscopic lesions of the intestinal mucosa.
The mucosal healing exploration needs the realization of an ileo-colonoscopy under general anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its too frequent repetition. we do not currently have noninvasive and reliable markers able to predict the occurrence of thrust of CD and allow the introduction of a more suitable treatment.
Indeed, relapse prevention is the best way to avoid complications and formation of lesions that lead to the irreversible medical treatment failure and surgery.
Since during the CD, it is the immunological changes that lead to inflammation and lesions, we make the assumption that the ability of certain markers immunological to predict a relapse of CD is higher than that of other in particular inflammatory markers.
This work should help to identify the profile of patients with CD in remission but at high risk of recurrence. It will specify i) the potential new markers immunological, from the pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally, the stress and the management of stressful events in the occurrence of a relapse.
This work also will specify the evolution of different markers at the moment of thrust
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Crohn's Disease | – | Biological: Biological samplings, Other: Questionnairespatients will have biological samplings (blood, urine and faecal sampling) and will fill questionnaires to assess their stress and adaptation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Crohn Disease
Key inclusion criteria (6 listed)
- Patient over 18 years.
- Patient with CD previously diagnosed according to standard criteria.
- Patient remission (HBS≤4) for at least 3 months and has not received corticosteroids (including budesonide) in the 3 months before.
- Patient without concomitant treatment of Crohn's disease or as stable dose (5-ASA, corticosteroids, immunosuppressants, anti-TNF) immunosuppressants (azathioprine, Purinethol, methotrexate) and / or anti-TNF and / or 5- amino salicylates (5-ASA) for at least 6 months.
- Patient who signed a consent.
Key exclusion criteria (12 listed)
- A patient with an active CD (HB score≥5).
- Patient who relapsed in the previous three months before inclusion.
- Patient who received corticosteroids (including budesonide) in the 6 months prior to inclusion.
- Patients on stable dose of non-anti-TNF in the 6 months prior to inclusion.
- Patient taking nonsteroidal anti-inflammatory drugs or antibiotics.
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 |
|---|---|---|
| Biological samplingsBlood, urine and faecal sampling every 3 months | Biological | Patients with Crohn's Disease |
| Questionnairespatients fill several questionnaires every month to assess stress and adaptation parameters | Other | Patients with Crohn's Disease |
Primary outcome
Correlation between new immunological markers rate and Crohn's Disease relapse
Time frame: within 15 months
This outcome will help us to show that regular monitoring of new immunological markers (serum markers of cytotoxicity of lymphocytes, pro- and anti-inflammatory cytokines and urinary and fecal neopterin) let us predict relapse of the disease
1 secondary outcome
Correlation between usual immunological markers rate and Crohn's Disease relapse
Time frame: within 15 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 24 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Hospices Civils de Lyon at 3 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 6 inclusion and 12 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 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Correlation between new immunological markers rate and Crohn's Disease relapse (time frame: within 15 months). 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 24 Jul 2015.