Lipid Mediators in Colonic Biopsies as Biomarkers of Disease Activity of Inflammatory Bowel Diseases (MICILIP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01990716
First received: November 15, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

We will quantify one of the lipid compounds (5,6 epoxy eicosatrienoic acid (5,6 EET), 5,6- EpoxyEicosaTrienoic acid) in colonic biopsies of Inflammatory Bowel Disease patients. We will evaluate its possible use as a pathological activity biomarker and its potential as a therapeutic target.

We hypothesized that 5,6-EET is present in human colonic tissues in varying quantities depending on the pathological state of the IBD patient.


Condition Intervention
Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Other: Colonic Biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Quantitative Analysis of Lipid Mediators in Colonic Biopsies From Patients With Inflammatory Bowel Diseases and From Control Patients.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Measure of 5,6-EET quantity in a colonic biopsy [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Mass spectrography analysis of the biopsies will be performed each time at least 10 samples are available


Secondary Outcome Measures:
  • Nature and quantity of Lipid metabolites as a function of the patient clinical profile (mapping) [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    This measure will be performed at the same time than the first outcome measure (each time at least 10 samples are available).


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IBD patients
Patients (diagnosed with IBD) having a screening colonic biopsy
Other: Colonic Biopsy

Colonoscopy or coloscopy can provide a visual diagnosis and grants the opportunity for biopsy or removal of suspected colorectal cancer lesions.

The endoscope is then passed through the anus up the rectum, the colon, and ultimately the terminal ileum. The endoscope has a movable tip and multiple channels for instrumentation, air, suction and light. Biopsies are frequently taken for histology, needed for cancer or IBD diagnosis.

Extra-biopsies for research purpose will only be performed if the clinician decides that they are necessary for the clinical diagnosis or for the disease follow-up.

For this protocol, collecting these extra biopsies should last under 5 minutes and should not extend the procedure by more than this time.

Control Group
individuals undergoing screening colonic biopsy for colon cancer or polyp detection, who have not been diagnosed with any intestinal pathology.
Other: Colonic Biopsy

Colonoscopy or coloscopy can provide a visual diagnosis and grants the opportunity for biopsy or removal of suspected colorectal cancer lesions.

The endoscope is then passed through the anus up the rectum, the colon, and ultimately the terminal ileum. The endoscope has a movable tip and multiple channels for instrumentation, air, suction and light. Biopsies are frequently taken for histology, needed for cancer or IBD diagnosis.

Extra-biopsies for research purpose will only be performed if the clinician decides that they are necessary for the clinical diagnosis or for the disease follow-up.

For this protocol, collecting these extra biopsies should last under 5 minutes and should not extend the procedure by more than this time.


Detailed Description:

The project is an exploratory physiopathological/translational pilot study, aiming at understanding the relative importance of the lipid compounds, especially 5,6-EET, in Inflammatory Bowel Diseases.

Using mass spectrometry, 5,6-EET and other 33 lipid metabolites will be quantified in situ in colonic biopsies from IBD patients and from control patients. We will compare quantities of 5,6-EET in inflammatory and non-inflammatory zones of biopsies from IBD patient to biopsies from control patient. We will establish a cluster of lipid compounds associated with pathological activity. We will determine the exposed profile of receptor lipid mediators expressing to the 5,6-EET lipid compound and one of its signalization.

All data will be submit to statistical analysis to confirm relevance.

We expect this pilot study to help us define 5,6-EET and other components of the same metabolic family as markers for IBD activity. It could point lipid mediators and their receptors as potential new therapeutic targets.

It will increase our knowledge on current treatment efficiency by evidencing lipid markers for the inflammatory condition.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

INCLUSION CRITERIA FOR IBD PATIENTS

  • Major/18 years and older
  • Covered by a health insurance plan
  • Patient having a screening colonoscopy for/with a suspicion of IBD or, IBD Patient, either in acute phase or in remission, having a therapeutic colonoscopy as part of his/her regular follow- up/usual care
  • Must be able to understand and voluntarily sign an informed consent prior to any study procedures

INCLUSION CRITERIA FOR IBD PATIENTS

  • Major/18 years and older Covered by a health insurance plan
  • Patients having a screening colonoscopy for polyp or cancer detection or patient undergoing a colic resection
  • Must be able to understand and voluntarily sign an informed consent prior to any study procedures

Exclusion Criteria:

EXCLUSION CRITERIA FOR IBD PATIENTS

  • Unable to comprehend the full nature and purpose of the study, and/or difficulty in communicating with the investigator
  • Deprivation of liberty by administrative or legal decision
  • Any other pathological or psychological condition considered by the investigator as interfering with the study (pregnancy, breastfeeding, cancer detection, AIDS, celiac disease)
  • Participation in another biomedical research/clinical trial with experimental medication within the last 3 months prior to the selection visit or patients still within a biomedical research exclusion period
  • Presence of cancerous lesions
  • Anatomopathological results excluding the possibility of an IBD
  • Contra-indications to carrying out a lower digestive endoscopy

EXCLUSION CRITERIA FOR CONTROL PATIENTS

  • Unable to comprehend the full nature and purpose of the study,
  • and/or difficulty in communicating with the investigator
  • Deprivation of liberty by administrative or legal decision
  • Participation in another biomedical research/clinical trial with experimental medication within the last 3 months prior to the selection visit or patients still within a biomedical research exclusion period
  • Contra-indications to carrying out a lower digestive endoscopy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990716

Contacts
Contact: Laurent Alric, MD, PhD 0561779751 ext +33 alric.l@chu-toulouse.fr
Contact: Nathalie Vergnolle, PhD 0632744500 ext +33 nathalie.vergnolle@inserm.fr

Locations
France
University Hospital Toulouse Recruiting
Toulouse, France, 31059
Contact: Laurent ALRIC, MD-PhD    0561779551 ext +33    alric.l@chu-toulouse.fr   
Contact: Nathalie VERGNOLLE, PhD    0562774500 ext +33    mathalie.vergnolle@chu-inserm.fr   
Principal Investigator: Laurent ALRIC, Md, PhD         
Sub-Investigator: Delphine BONNET         
Sub-Investigator: Sophie THEBAULT         
Sub-Investigator: Nicolas SIGUR         
Sub-Investigator: Louis BUSCAIL         
Sub-Investigator: Jacques MOREAU         
Sub-Investigator: Audrey HAENNIG         
Sub-Investigator: Barbara BOURNET         
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01990716     History of Changes
Other Study ID Numbers: 12 393 02, AOL 2012
Study First Received: November 15, 2013
Last Updated: July 23, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
Adult
Colonoscopy

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Crohn Disease
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Colitis
Colonic Diseases

ClinicalTrials.gov processed this record on September 22, 2014