Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease

July 23, 2015 updated by: Hospices Civils de Lyon

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

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

  • France
      • Clermont-ferrand, France, 63000
        • CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie
      • Pierre Benite, France, 69495
        • Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Hépato-Gastroentérologie
      • Saint-etienne, France, 42055
        • CHU Hôpital Nord - Service d'Hépato-Gastroentérologie

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Crohn Disease

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.-

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Biological: Biological samplings
Blood, urine and faecal sampling every 3 months
Other: Questionnaires
patients fill several questionnaires every month to assess stress and adaptation parameters

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
within 15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between usual immunological markers rate and Crohn's Disease relapse
Time Frame: within 15 months
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)
within 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2010.630

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.

Clinical Trials on Crohn Disease

Clinical Trials on Biological samplings

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings